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Efficacy, Safety and Tolerability of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type

Primary Purpose

Agitation in Patients With Dementia of the Alzheimer's Type

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

AVP-786

Placebo

About this trial

This is an interventional treatment trial for Agitation in Patients With Dementia of the Alzheimer's Type focused on measuring Agitation, Dementia, Alzheimer's disease

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Diagnosis of probable Alzheimer's Disease (AD) according to the 2011 National Institute on Aging-Alzheimer's Association (NIA-AA) working groups criteria
The participant has clinically significant, moderate/severe agitation at the time of screening and for at least 2 weeks prior to randomization
The diagnosis of agitation must meet the International Psychogeriatric Association (IPA) provisional definition of agitation
Either out patients or residents of an assisted-living facility or a skilled nursing home
Clinical Global Impression of Severity of Illness (CGIS) score assessing Agitation is >= 4 (moderately ill) at screening and baseline
Mini-Mental State Examination (MMSE) score is between 6 and 26 (inclusive) at screening and baseline
Caregiver who is able and willing to comply with all required study procedures. In order to qualify as a reliable informant (i.e., caregiver) capable of assessing changes in participant's condition during the study, the individual must spend a minimum of 2 hours per day for 4 days per week with the participant.

Exclusion Criteria:

Participant has dementia predominantly of non-Alzheimer's type (e.g., vascular dementia, frontotemporal dementia, Parkinson's disease, substance-induced dementia)
Participants with co-existent clinically significant or unstable systemic diseases that could confound the interpretation of the safety results of the study (e.g., malignancy, poorly controlled diabetes, poorly controlled hypertension, unstable pulmonary, renal or hepatic disease, unstable ischemic cardiac disease, dilated cardiomyopathy, or unstable valvular heart disease)
Participant with myasthenia gravis

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Arm Label

Stage 1: Placebo

Stage 1: AVP-786-18 (d6-DM 18 mg/Q 4.9 mg)

Stage 1: AVP-786-28 (d6-DM 28 mg/Q 4.9 mg)

Stage 2: Placebo

Stage 1: AVP-786-18 (d6-DM 18 mg/Q 4.9 mg) to: Stage 2: AVP-786-18 (d6-DM 18 mg/Q 4.9 mg)

Stage 1: AVP-786-28 (d6-DM 28 mg/Q 4.9 mg) to Stage 2: AVP-786-28 (d6-DM 28 mg/Q 4.9 mg)

Experimental: Stage 1: Placebo to: Stage 2: AVP-786-18 d6-DM 18 mg/Q 4.9 mg

Stage 1: Placebo to: Stage 2: AVP-786-28 d6 DM 28 mg/Q 4.9 mg

Arm Description

Participants received matching placebo orally twice daily (BID) for 6 weeks (Days 1-42) in Stage 1. Participants who completed Stage 1 were eligible to Participate in Stage 2.

Participants received AVP-786-18 mg orally once daily (QD) in the morning and placebo orally QD in the evening for the first 7 days, followed by AVP-786-18 mg orally BID for the remaining 5 weeks (Days 8-42). Participants who completed Stage 1 were eligible to participate in Stage 2.

Participants received AVP-786-18 mg orally QD in the morning and placebo orally QD in the evening for the first 7 days, followed by AVP-786-18 mg orally BID for 2 weeks (Days 8-21). From Day 22, participants received AVP-786-28 mg orally BID for the remaining 3 weeks. Participants who completed Stage 1 were eligible to participate in Stage 2.

Participants who received matching placebo orally BID for 6 consecutive weeks in Stage 1 were re-randomized in Stage 2 to receive the study drug or placebo from Day 43 to Day 85.

Participants who received AVP-786-18 mg in Stage 1 continued to receive AVP-786-18 mg orally BID for the 6 weeks (Days 43-85) in Stage 2..

Participants who received AVP-786-28 mg in Stage 1 continued to receive AVP-786-28 mg orally BID for 6 weeks (Days 43-85) in Stage 2

Participants who were placebo responders or non-responders in Stage 1 received AVP-786-18 for 1 week, orally, QD, followed by AVP-786-18 BID for 2 weeks; followed by AVP-786-28 BID for the last 3 weeks.

Participants who were placebo responders or non-responders in Stage 1 received AVP-786-28 for 1 week, orally, QD, followed by AVP-786-28 BID for 2 weeks; followed by AVP-786-28 BID for the last 3 weeks.

Outcomes

Primary Outcome Measures

Stage 1 and Stage 2: Change From Baseline in the Cohen-Mansfield Agitation Inventory (CMAI) Composite Score to Week 6 and Week 12

The CMAI score is used to assess the frequency of manifestations of agitated behaviors in participants. The CMAI consists of 29 agitated behaviors that are rated on a 7-point scale of frequency: 1, never; 2, less than once a week; 3, once or twice a week; 4, several times a week; 5, once or twice a day; 6, several times a day; 7, several times an hour. The CMAI total score ranges from 29 to 203. Higher scores indicate worsening of the condition. Change from Baseline was calculated as the post-Baseline score minus the Baseline score.

Secondary Outcome Measures

Least Squares Mean Modified Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (mADCS-CGIC)-Agitation Score at Week 6 and Week 12

The intent of the ADCS version of the CGIC is to provide a means to reliably assess the global impression of change from Baseline in a clinical trial. The mADCS-CGIC is a modification of the ADCS-CGIC instrument that focuses specifically on agitation. The participants are asked to rate their impression of change from Baseline as: 1, marked improvement; 2, moderate improvement; 3, minimal improvement; 4, no change; 5, minimal worsening; 6, moderate worsening; 7, marked worsening. Baseline was defined as the last non-missing assessment prior to Stage 1 randomization. Treatment effects were estimated at each stage by analysis of covariance (ANCOVA) with fixed effects for treatment, Baseline CMAI Total score, and in the Stage 1 model, Baseline NPI AA (≤ 6 versus [vs] > 6), risk assessments for falls (normal/mild vs moderate/severe), Baseline concomitant use of antipsychotic medications (yes vs no). Missing values were imputed by last observation carried forward (LOCF) within each stage.

Stage 1 and Stage 2: Change From Baseline in the Neuropsychiatric Inventory (NPI) Agitation/Aggression Domain Score to Week 6 and Week 12

The NPI is a retrospective interview covering 12 neuropsychiatric symptom domains and is used to evaluate psychopathology, neuropsychiatric manifestations, and caregiver distress. The Agitation/Aggression domain is designed to collect information on the behavioral aspects of agitation/aggression in participants with probable Alzheimer's Disease (AD) and clinically meaningful agitation secondary to AD. Each NPI domain is rated by the caregiver for symptom frequency and severity. Symptom frequency is rated as: 1, occasionally; 2, often; 3, frequently; 4, very frequently. Symptom severity is rated as: 1, mild; 2, moderate; 3, severe. The total domain score is calculated as the frequency score multiplied by the severity score and thus ranges from 1 to 12. Higher scores indicate worsening symptoms. Change from Baseline was calculated as the post-Baseline score minus the Baseline score.

Stage 1 and Stage 2: Change From Baseline in the NPI Caregiver Distress Score to Week 6 and Week 12

The NPI is a retrospective interview covering 12 neuropsychiatric symptom domains and is used to evaluate caregiver distress. Each NPI domain is rated by the caregiver for symptom frequency and severity. Symptom frequency is rated as: 1, occasionally; 2, often; 3, frequently; 4, very frequently. Symptom severity is rated as: 1, mild; 2, moderate; 3, marked severe. The total caregiver distress score is calculated as the frequency score multiplied by the severity score and thus ranges from 1 to 12. Higher scores indicate worsening symptoms. Change from Baseline was calculated as the post-Baseline score minus the Baseline score.

Stage 1 and Stage 2: Change From Baseline in the NPI Aberrant Motor Behavior Domain Score to Week 6 and Week 12

The NPI is a retrospective interview covering 12 neuropsychiatric symptom domains and is used to evaluate aberrant motor behavior. Each NPI domain is rated by the caregiver for symptom frequency and severity. Symptom frequency is rated as: 1, occasionally; 2, often; 3, frequently; 4, very frequently. Symptom severity is rated as: 1, mild; 2, moderate; 3, severe. The total domain score is calculated as the frequency score multiplied by the severity score and thus ranges from 1 to 12. Higher scores indicate worsening of the symptoms. Change from Baseline was calculated as the post-Baseline score minus the Baseline score.

Stage 1 and Stage 2: Change From Baseline in the Zarit Burden Interview (ZBI) Score to Week 6 and Week 12

The ZBI is a 22-item scale used to assess the impact of a participant with dementia and also other illnesses on the caregiver's burden. For each item of the scale, the caregiver indicates how often they feel the burden (never, rarely, sometimes, quite frequently, or nearly always). The score ranges from 0 to 88 and is determined by adding the numbered responses of the individual items. Higher scores indicate greater caregiver distress. Change from Baseline was calculated as the post-Baseline score minus the Baseline score. Treatment effects were estimated at each stage by ANCOVA with fixed effects for treatment, Baseline, and in the Stage 1 model, Baseline NPI AA (≤ 6 versus > 6), risk assessments for falls (normal/mild versus moderate/severe), Baseline concomitant use of antipsychotic medications (yes versus no). Missing values were imputed by LOCF within each stage.

Stage 1 and Stage 2: Change From Baseline in the NPI Irritability/Lability Domain Score to Week 6 and Week 12

The NPI is a retrospective interview covering 12 neuropsychiatric symptom domains, including the irritability/lability domain score. Each NPI domain is rated by the caregiver for symptom frequency and severity. Symptom frequency is rated as: 1, occasionally; 2, often; 3, frequently; 4, very frequently. Symptom severity is rated as: 1, mild; 2, moderate; 3, severe. The total domain score is calculated as the frequency score multiplied by the severity score and thus ranges from 1 to 12. Higher scores indicate worsening of the symptoms. Change from Baseline was calculated as the post-Baseline score minus the Baseline score.

Stage 1 and Stage 2: Change From Baseline in the NPI Total Score to Week 6 and Week 12

NPI evaluates both frequency and severity of 12 neuropsychiatric disturbances including delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, nighttime behaviors, as well as appetite/eating. Total domain score= frequency x severity and thus ranges from 1 to 12. NPI domain is rated by caregiver for symptom frequency and severity. Frequency is rated as: 1=occasionally, 2=often, 3= frequently, and 4=very frequently. Severity is rated as: 1=mild; 2= moderate, and 3=severe. Frequency and severity rating scales has defined anchor points to enhance reliability of caregiver responses. Caregiver distress is rated for each positive neuropsychiatric symptom using following anchored scores. It is rated as 0=not at all, 1=minimal, 3=moderate, 4=severe, 5=very severe. Total score is calculated by adding the individual Item scores, to yield a possible total scores of 0 to 144.

Stage 1 and Stage 2: Change From Baseline in the Clinical Global Impression of Severity of Illness (CGIS)-Agitation Domain Score to Week 6 and Week 12

The CGIS-Agitation is an observer-rated scale that measures illness severity. CGIS is used to assess the severity of agitation. The CGIS score is rated on a 7-point scale (1 = normal, not at all ill; 7 = among the most extremely ill participants). Change from Baseline was calculated as the post-Baseline score minus the Baseline score. Treatment effects were estimated at each stage by ANCOVA with fixed effects for treatment, Baseline, and in the Stage 1 model, Baseline NPI AA (≤ 6 versus > 6), risk assessments for falls (normal/mild versus moderate/severe), Baseline concomitant use of antipsychotic medications (yes versus no). Missing values were imputed by LOCF within each stage.

Stage 1 and Stage 2: Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Rating at Week 6 and Week 12

The ADCS-CGIC rating scale provides a reliable means to assess change from a Baseline level of global function within the time frame of the trial. ADCS-CGIC-Overall focuses on the clinician's observations of change in the participant's cognitive, functional, and behavioral performance. The ADCS-CGIC-Overall responses (1-7) are rated as: 1 = marked improvement, 2 = moderate improvement, 3 = minimal improvement, 4 = no change, 5 = minimal worsening, 6 = moderate worsening, or 7 = marked worsening. Treatment effects were estimated at each stage by ANCOVA with fixed effects for treatment, Baseline CMAI Total score, and in the Stage 1 model, Baseline NPI AA (≤ 6 versus > 6), risk assessments for falls (normal/mild versus moderate/severe), Baseline concomitant use of antipsychotic medications (yes versus no). Missing values were imputed by LOCF within each stage.

Stage 1 and Stage 2: Patient Global Impression of Change (PGIC) Score at Week 6 and Week 12

The PGIC is a 7-point (1-7) scale used to assess treatment response: 1 = very much improved, = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, or 7 = very much worse. Treatment effects were estimated at each stage by ANCOVA with fixed effects for treatment, Baseline CMAI Total score, and in the Stage 1 model, Baseline NPI AA (≤ 6 versus > 6), risk assessments for falls (normal/mild versus moderate/severe), Baseline concomitant use of antipsychotic medications (yes vs no). Missing values were imputed by LOCF within each stage.

Stage 1 and Stage 2: Change From Baseline in the Dementia Quality of Life (DEMQOL) Score to Week 6 and Week 12

The DEMQOL scale is used to evaluate health-related QOL in participants with dementia and their caregivers. There are 2 versions of the DEMQOL: a 28-item version (rated by the participant); and a 31-item version (DEMQOL-proxy, rated by the caregiver). Both versions are recommended for evaluating participants (and their caregivers) with mild to moderate dementia. The DEMQOL total score ranges from 28 to 112. The DEMQOL-proxy is used for participants with severe dementia; the total score ranges from 31 to 124. For both versions, higher scores indicate greater QOL. Change from Baseline was calculated as the post-Baseline score minus the Baseline score. Treatment effects were estimated at each stage by ANCOVA with fixed effects for treatment, Baseline, and in the Stage 1 model, Baseline NPI AA (≤ 6 vs > 6), risk assessments for falls (normal/mild vs moderate/severe), Baseline concomitant use of antipsychotic medications (yes vs no). Missing values were imputed by LOCF within each stage.

Stage 1 and Stage 2: Change From Baseline in the Cornell Scale for Depression in Dementia (CSDD) Score to Week 6 and Week 12

The CSDD scale is used to assess signs/symptoms of major depression in participants with dementia. CSDD has 19 items, and each item is rated for severity on the following scale of 0 to 2 (0 =absent, 1= mild/intermittent 2=severe). CSDD score is calculated by summing non-missing scores from each item score. The scale ranges from 0-no depression to 38 maximum depressions. Scores above 10 indicate a probable major depression, above 18 indicate a definite major depression, and below 6 as a rule are associated with the absence of significant depressive symptoms. Higher score indicated maximum depression.

Stage 2: Percentage of Participants With General Medical Health Rating (GMHR) Score

The GMHR is a global clinical rating for medical health, designed to quantify in a single number (1 to 4) the severity of general comorbidity in a participant with dementia. The ratings are: 1 = poor; 2 = fair; 3 = good; 4 = excellent to very good. Data was collected for the treatment arm groups as pre-specified in the protocol for this outcome measure.

Stage 1 and Stage 2: Change From Baseline in the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) Score to Week 6 and Week 12

The ADAS is designed to evaluate the cognitive and non-cognitive behavioral dysfunction characteristics of participants with AD. The cognitive subscale (ADAS-cog) consists of 11 subsets related to memory, praxis, and language. ADAS-cog scores range from 0 to 70. Higher scores indicate greater cognitive impairment. The ADAS-cog is assessed for participants with an Mini-Mental State Examination (MMSE) score of ≥10 at the Baseline Visit. Change from Baseline was calculated as the post-Baseline score minus the Baseline score. Treatment effects were estimated at each stage by ANCOVA with fixed effects for treatment, Baseline, and in the Stage 1 model, Baseline NPI AA (≤ 6 versus > 6), risk assessments for falls (normal/mild versus moderate/severe), Baseline concomitant use of antipsychotic medications (yes vs no). Missing values were imputed by LOCF within each stage.

Stage 1: Resource Utilization in Dementia (RUD): Percentage of Caregiver Who Reported That Their Responsibilities Affected Their Work and Who Visited Health Care Professionals

RUD evaluates dementia participants utilization of formal and informal healthcare resources, including hospitalizations and doctor visits, living assistance, and time spent by nonprofessional caregivers. The RUD is administered as a semi-structured interview with the participant's primary caregiver and contains 2 sections; one focusing on caregiver impact (loss of work and leisure time incurred by caregiver) and the other focusing on the participant's use of healthcare resources. Information of caregivers who reported their responsibilities affected their work and who visited healthcare professionals from the interviews during Stage 1 is reported for this outcome measure. Data was collected for the treatment arm groups as pre-specified in the protocol for this outcome measure.

Stage 2: Resource Utilization in Dementia (RUD): Percentage of Caregiver Who Reported That Their Responsibilities Affected Their Work and Who Visited Health Care Professionals

RUD evaluates dementia participants utilization of formal and informal healthcare resources, including hospitalizations and doctor visits, living assistance, and time spent by nonprofessional caregivers. The RUD is administered as a semi-structured interview with the participant's primary caregiver and contains 2 sections; one focusing on caregiver impact (loss of work and leisure time incurred by caregiver) and the other focusing on the participant's use of healthcare resources. Information of caregivers who reported their responsibilities affected their work and who visited healthcare professionals from the interviews during Stage 2 is reported for this outcome measure. Data was collected for the treatment arm groups as pre-specified in the protocol for this outcome measure.

Stage 1: Resource Utilization in Dementia (RUD): Number of Hours Per Day the Caregiver Spent Assisting the Participant

RUD evaluates dementia participants utilization of formal, informal healthcare resources, including hospitalizations, doctor visits, living assistance, time spent by nonprofessional caregivers. Information on hours per day caregiver spent assisting participant from interviews during Stage 1 is reported for this outcome measure, where the following questions (Q), Q1= On typical care day during last 30 days, how much time per day did you assist participant with tasks such as toilet visits, eating, dressing, grooming, walking, bathing? Q2= On typical care day during the last 30 days, how much time per day did you assist participant with tasks as (shopping, food preparation, housekeeping, laundry, transportation, taking medication, managing financial matters?; Q3= On typical care day during last 30 days, how much time per day did you spend supervising (preventing dangerous events)?(Q3). Data is collected for treatment arm groups as pre-specified in protocol for this outcome measure.

Stage 2: Resource Utilization in Dementia (RUD): Number of Hours Per Day the Caregiver Spent Assisting the Participant

Stage 1: Resource Utilization in Dementia (RUD) Score: Number of Days the Caregiver Spent Assisting the Participant

RUD evaluates dementia participants utilization of formal, informal healthcare resources, including hospitalizations, doctor visits, living assistance, time spent by nonprofessional caregivers. Information on days caregiver spent assisting participant from interviews during Stage 1 is reported for outcome measure, where following questions (Q), Q1= During last 30 days, how many days did you spend providing these (toilet visits, eating, dressing, grooming, walking, bathing) services to participant?; Q2= On typical care day during last 30 days, how much time per day did you assist participant with tasks such as shopping, food preparation, housekeeping, laundry, transportation, taking medication, managing financial matters?; Q3= During last 30 days, how many days did you spend providing these services (supervising) to the participant?. Data is collected for the treatment arm groups as pre-specified in the protocol for this outcome measure.

12-Week Parallel Group: Resource Utilization in Dementia (RUD) Score: Number of Days the Caregiver Spent Assisting the Participant

RUD evaluates dementia participants utilization of formal, informal healthcare resources, including hospitalizations, doctor visits, living assistance, time spent by nonprofessional caregivers. Information on days caregiver spent assisting participant from interviews during Stage 1 is reported for outcome measure, where following questions (Q), Q1= During last 30 days, how many days did you spend providing these (toilet visits, eating, dressing, grooming, walking, bathing) services to participant?; Q2= On typical care day during last 30 days, how much time per day did you assist participant with tasks such as shopping, food preparation, housekeeping, laundry, transportation, taking medication, managing financial matters?; Q3= During last 30 days, how many days did you spend providing these services (supervising) to the participant?. Data is collected for the treatment arm groups as pre-specified in the protocol for this outcome measure.

Full Information

NCT ID

NCT02442765

First Posted

May 11, 2015

Last Updated

January 18, 2023

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02442765

Brief Title

Efficacy, Safety and Tolerability of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type

Official Title

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 (Deuterated [d6]-Dextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Completed

Study Start Date

July 23, 2015 (Actual)

Primary Completion Date

January 30, 2019 (Actual)

Study Completion Date

February 27, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Participants with agitation secondary to dementia of the Alzheimer's type. The diagnosis of probable Alzheimer's disease (AD) was to be based on the "2011 Diagnostic Guidelines for Alzheimer's Disease" issued by the National Institute on Aging (NIA)-Alzheimer's Association (AA) workgroups.

Detailed Description

Eligible participants for this study must have had a diagnosis of probable AD and must have had clinically meaningful agitation secondary to AD. This was to be a multicenter, randomized, placebo-controlled study, consisting of 12 weeks of treatment. Approximately 380 participants were to be enrolled at approximately 60 centers in North America. Study medication was to be administered orally twice-daily from Day 1 through Day 85. Screening was to occur within approximately 4 weeks prior to randomization. Following screening procedures for assessment of inclusion and exclusion criteria, eligible participants were to be randomized into the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Agitation in Patients With Dementia of the Alzheimer's Type

Keywords

Agitation, Dementia, Alzheimer's disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

Sequential parallel comparison design

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

387 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Stage 1: Placebo

Arm Type

Placebo Comparator

Arm Description

Participants received matching placebo orally twice daily (BID) for 6 weeks (Days 1-42) in Stage 1. Participants who completed Stage 1 were eligible to Participate in Stage 2.

Arm Title

Stage 1: AVP-786-18 (d6-DM 18 mg/Q 4.9 mg)

Arm Type

Experimental

Arm Description

Arm Title

Stage 1: AVP-786-28 (d6-DM 28 mg/Q 4.9 mg)

Arm Type

Experimental

Arm Description

Arm Title

Stage 2: Placebo

Arm Type

Placebo Comparator

Arm Description

Participants who received matching placebo orally BID for 6 consecutive weeks in Stage 1 were re-randomized in Stage 2 to receive the study drug or placebo from Day 43 to Day 85.

Arm Title

Stage 1: AVP-786-18 (d6-DM 18 mg/Q 4.9 mg) to: Stage 2: AVP-786-18 (d6-DM 18 mg/Q 4.9 mg)

Arm Type

Experimental

Arm Description

Participants who received AVP-786-18 mg in Stage 1 continued to receive AVP-786-18 mg orally BID for the 6 weeks (Days 43-85) in Stage 2..

Arm Title

Stage 1: AVP-786-28 (d6-DM 28 mg/Q 4.9 mg) to Stage 2: AVP-786-28 (d6-DM 28 mg/Q 4.9 mg)

Arm Type

Experimental

Arm Description

Participants who received AVP-786-28 mg in Stage 1 continued to receive AVP-786-28 mg orally BID for 6 weeks (Days 43-85) in Stage 2

Arm Title

Experimental: Stage 1: Placebo to: Stage 2: AVP-786-18 d6-DM 18 mg/Q 4.9 mg

Arm Type

Experimental

Arm Description

Arm Title

Stage 1: Placebo to: Stage 2: AVP-786-28 d6 DM 28 mg/Q 4.9 mg

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

AVP-786

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Stage 1 and Stage 2: Change From Baseline in the Cohen-Mansfield Agitation Inventory (CMAI) Composite Score to Week 6 and Week 12

Description

Time Frame

Stage 1: Baseline, Week 6; Stage 2: Baseline (Week 6), Week 12

Secondary Outcome Measure Information:

Title

Least Squares Mean Modified Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (mADCS-CGIC)-Agitation Score at Week 6 and Week 12

Description

Time Frame

Stage 1 Week 6; Stage 2 Week 12

Title

Stage 1 and Stage 2: Change From Baseline in the Neuropsychiatric Inventory (NPI) Agitation/Aggression Domain Score to Week 6 and Week 12

Description

Time Frame

Stage 1: Baseline, Week 6; Stage 2: Baseline (Week 6), Week 12

Title

Stage 1 and Stage 2: Change From Baseline in the NPI Caregiver Distress Score to Week 6 and Week 12

Description

Time Frame

Stage 1: Baseline, Week 6; Stage 2: Baseline (Week 6), Week 12

Title

Stage 1 and Stage 2: Change From Baseline in the NPI Aberrant Motor Behavior Domain Score to Week 6 and Week 12

Description

Time Frame

Stage 1: Baseline, Week 6; Stage 2: Baseline (Week 6), Week 12

Title

Stage 1 and Stage 2: Change From Baseline in the Zarit Burden Interview (ZBI) Score to Week 6 and Week 12

Description

Time Frame

Stage 1: Baseline, Week 6; Stage 2: Baseline (Week 6), Week 12

Title

Stage 1 and Stage 2: Change From Baseline in the NPI Irritability/Lability Domain Score to Week 6 and Week 12

Description

Time Frame

Stage 1: Baseline, Week 6; Stage 2: Baseline (Week 6), Week 12

Title

Stage 1 and Stage 2: Change From Baseline in the NPI Total Score to Week 6 and Week 12

Description

Time Frame

Stage 1: Baseline, Week 6; Stage 2: Baseline (Week 6), Week 12

Title

Stage 1 and Stage 2: Change From Baseline in the Clinical Global Impression of Severity of Illness (CGIS)-Agitation Domain Score to Week 6 and Week 12

Description

Time Frame

Stage 1: Baseline, Week 6; Stage 2: Baseline (Week 6), Week 12

Title

Stage 1 and Stage 2: Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Rating at Week 6 and Week 12

Description

Time Frame

Stage 1: Baseline, Week 6; Stage 2: Baseline (Week 6), Week 12

Title

Stage 1 and Stage 2: Patient Global Impression of Change (PGIC) Score at Week 6 and Week 12

Description

Time Frame

Stage 1: Baseline, Week 6; Stage 2: Baseline (Week 6), Week 12

Title

Stage 1 and Stage 2: Change From Baseline in the Dementia Quality of Life (DEMQOL) Score to Week 6 and Week 12

Description

Time Frame

Stage 1: Baseline, Week 6; Stage 2: Baseline (Week 6), Week 12

Title

Stage 1 and Stage 2: Change From Baseline in the Cornell Scale for Depression in Dementia (CSDD) Score to Week 6 and Week 12

Description

Time Frame

Stage 1: Baseline, Week 6; Stage 2: Baseline (Week 6), Week 12

Title

Stage 2: Percentage of Participants With General Medical Health Rating (GMHR) Score

Description

Time Frame

Baseline; Week 12

Title

Stage 1 and Stage 2: Change From Baseline in the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) Score to Week 6 and Week 12

Description

Time Frame

Stage 1: Baseline, Week 6; Stage 2: Baseline (Week 6), Week 12

Title

Stage 1: Resource Utilization in Dementia (RUD): Percentage of Caregiver Who Reported That Their Responsibilities Affected Their Work and Who Visited Health Care Professionals

Description

Time Frame

Stage 1: Week 6

Title

Stage 2: Resource Utilization in Dementia (RUD): Percentage of Caregiver Who Reported That Their Responsibilities Affected Their Work and Who Visited Health Care Professionals

Description

RUD evaluates dementia participants utilization of formal and informal healthcare resources, including hospitalizations and doctor visits, living assistance, and time spent by nonprofessional caregivers. The RUD is administered as a semi-structured interview with the participant's primary caregiver and contains 2 sections; one focusing on caregiver impact (loss of work and leisure time incurred by caregiver) and the other focusing on the participant's use of healthcare resources. Information of caregivers who reported their responsibilities affected their work and who visited healthcare professionals from the interviews during Stage 2 is reported for this outcome measure. Data was collected for the treatment arm groups as pre-specified in the protocol for this outcome measure.

Time Frame

Stage 2: Week 12

Title

Stage 1: Resource Utilization in Dementia (RUD): Number of Hours Per Day the Caregiver Spent Assisting the Participant

Description

Time Frame

Stage 1: Week 6

Title

Stage 2: Resource Utilization in Dementia (RUD): Number of Hours Per Day the Caregiver Spent Assisting the Participant

Description

Time Frame

Stage 2: Week 12

Title

Stage 1: Resource Utilization in Dementia (RUD) Score: Number of Days the Caregiver Spent Assisting the Participant

Description

RUD evaluates dementia participants utilization of formal, informal healthcare resources, including hospitalizations, doctor visits, living assistance, time spent by nonprofessional caregivers. Information on days caregiver spent assisting participant from interviews during Stage 1 is reported for outcome measure, where following questions (Q), Q1= During last 30 days, how many days did you spend providing these (toilet visits, eating, dressing, grooming, walking, bathing) services to participant?; Q2= On typical care day during last 30 days, how much time per day did you assist participant with tasks such as shopping, food preparation, housekeeping, laundry, transportation, taking medication, managing financial matters?; Q3= During last 30 days, how many days did you spend providing these services (supervising) to the participant?. Data is collected for the treatment arm groups as pre-specified in the protocol for this outcome measure.

Time Frame

Stage 1: Week 6

Title

12-Week Parallel Group: Resource Utilization in Dementia (RUD) Score: Number of Days the Caregiver Spent Assisting the Participant

Description

RUD evaluates dementia participants utilization of formal, informal healthcare resources, including hospitalizations, doctor visits, living assistance, time spent by nonprofessional caregivers. Information on days caregiver spent assisting participant from interviews during Stage 1 is reported for outcome measure, where following questions (Q), Q1= During last 30 days, how many days did you spend providing these (toilet visits, eating, dressing, grooming, walking, bathing) services to participant?; Q2= On typical care day during last 30 days, how much time per day did you assist participant with tasks such as shopping, food preparation, housekeeping, laundry, transportation, taking medication, managing financial matters?; Q3= During last 30 days, how many days did you spend providing these services (supervising) to the participant?. Data is collected for the treatment arm groups as pre-specified in the protocol for this outcome measure.

Time Frame

12-Week Parallel Group: Week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Diagnosis of probable Alzheimer's Disease (AD) according to the 2011 National Institute on Aging-Alzheimer's Association (NIA-AA) working groups criteria The participant has clinically significant, moderate/severe agitation at the time of screening and for at least 2 weeks prior to randomization The diagnosis of agitation must meet the International Psychogeriatric Association (IPA) provisional definition of agitation Either out patients or residents of an assisted-living facility or a skilled nursing home Clinical Global Impression of Severity of Illness (CGIS) score assessing Agitation is >= 4 (moderately ill) at screening and baseline Mini-Mental State Examination (MMSE) score is between 6 and 26 (inclusive) at screening and baseline Caregiver who is able and willing to comply with all required study procedures. In order to qualify as a reliable informant (i.e., caregiver) capable of assessing changes in participant's condition during the study, the individual must spend a minimum of 2 hours per day for 4 days per week with the participant. Exclusion Criteria: Participant has dementia predominantly of non-Alzheimer's type (e.g., vascular dementia, frontotemporal dementia, Parkinson's disease, substance-induced dementia) Participants with co-existent clinically significant or unstable systemic diseases that could confound the interpretation of the safety results of the study (e.g., malignancy, poorly controlled diabetes, poorly controlled hypertension, unstable pulmonary, renal or hepatic disease, unstable ischemic cardiac disease, dilated cardiomyopathy, or unstable valvular heart disease) Participant with myasthenia gravis

Facility Information:

Facility Name

Clinical Research Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85032

Country

United States

Facility Name

Clinical Research Site

City

Scottsdale

State/Province

Arizona

ZIP/Postal Code

85254

Country

United States

Facility Name

Clinical Research Site

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72209

Country

United States

Facility Name

Clinical Research Site#1

City

Irvine

State/Province

California

ZIP/Postal Code

92697

Country

United States

Facility Name

Clinical Research Site#2

City

Irvine

State/Province

California

ZIP/Postal Code

92697

Country

United States

Facility Name

Clinical Research Site

City

Long Beach

State/Province

California

ZIP/Postal Code

90806

Country

United States

Facility Name

Clinical Research Site

City

Oceanside

State/Province

California

ZIP/Postal Code

92056

Country

United States

Facility Name

Clinical Research Site

City

Orange

State/Province

California

ZIP/Postal Code

92868

Country

United States

Facility Name

Clinical Research Site#1

City

San Diego

State/Province

California

ZIP/Postal Code

92103

Country

United States

Facility Name

Clinical Research Site#2

City

San Diego

State/Province

California

ZIP/Postal Code

92103

Country

United States

Facility Name

Clinical Research Site

City

Santa Ana

State/Province

California

ZIP/Postal Code

92704

Country

United States

Facility Name

Clinical Research Site

City

Tustin

State/Province

California

ZIP/Postal Code

92780

Country

United States

Facility Name

Clinical Research Site

City

Denver

State/Province

Colorado

ZIP/Postal Code

80209

Country

United States

Facility Name

Clinical Research Site

City

Cromwell

State/Province

Connecticut

ZIP/Postal Code

06416

Country

United States

Facility Name

Clinical Research Site

City

New London

State/Province

Connecticut

ZIP/Postal Code

06320

Country

United States

Facility Name

Clinical Research Site

City

Norwalk

State/Province

Connecticut

ZIP/Postal Code

06851

Country

United States

Facility Name

Clinical Research Site

City

Atlantis

State/Province

Florida

ZIP/Postal Code

33462

Country

United States

Facility Name

Clinical Research Site

City

Boca Raton

State/Province

Florida

ZIP/Postal Code

33428

Country

United States

Facility Name

Clinical Research Site

City

Brandon

State/Province

Florida

ZIP/Postal Code

33511

Country

United States

Facility Name

Clinical Research Site#1

City

Coral Gables

State/Province

Florida

ZIP/Postal Code

33134

Country

United States

Facility Name

Clinical Research Site#2

City

Coral Gables

State/Province

Florida

ZIP/Postal Code

33134

Country

United States

Facility Name

Clinical Research Site#3

City

Coral Gables

State/Province

Florida

ZIP/Postal Code

33134

Country

United States

Facility Name

Clinical Research Site#1

City

Deerfield Beach

State/Province

Florida

ZIP/Postal Code

33064

Country

United States

Facility Name

Clinical Research Site

City

Doral

State/Province

Florida

ZIP/Postal Code

33166

Country

United States

Facility Name

Clinical Research Site

City

Hialeah

State/Province

Florida

ZIP/Postal Code

33012

Country

United States

Facility Name

Clinical Research Site#1

City

Hialeah

State/Province

Florida

ZIP/Postal Code

33016

Country

United States

Facility Name

Clinical Research Site#2

City

Hialeah

State/Province

Florida

ZIP/Postal Code

33016

Country

United States

Facility Name

Clinical Research Site

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32256

Country

United States

Facility Name

Clinical Research Site

City

Kendall

State/Province

Florida

ZIP/Postal Code

33175

Country

United States

Facility Name

Clinical Research Site

City

Kissimmee

State/Province

Florida

ZIP/Postal Code

34741

Country

United States

Facility Name

Clinical Research Site

City

Kissimmee

State/Province

Florida

ZIP/Postal Code

34744

Country

United States

Facility Name

Clinical Research Site

City

Lake Worth

State/Province

Florida

ZIP/Postal Code

33449

Country

United States

Facility Name

Clinical Research Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33122

Country

United States

Facility Name

Clinical Research Site#1

City

Miami

State/Province

Florida

ZIP/Postal Code

33125

Country

United States

Facility Name

Clinical Research Site#2

City

Miami

State/Province

Florida

ZIP/Postal Code

33125

Country

United States

Facility Name

Clinical Research Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33126

Country

United States

Facility Name

Clinical Research Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33133

Country

United States

Facility Name

Clinical Research Site#1

City

Miami

State/Province

Florida

ZIP/Postal Code

33135

Country

United States

Facility Name

Clinical Research Site#2

City

Miami

State/Province

Florida

ZIP/Postal Code

33135

Country

United States

Facility Name

Clinical Research Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

Facility Name

Clinical Research Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33137

Country

United States

Facility Name

Clinical Research Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33144

Country

United States

Facility Name

Clinical Research Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33145

Country

United States

Facility Name

Clinical Research Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33165

Country

United States

Facility Name

Clinical Research Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33175

Country

United States

Facility Name

Clinical Research Site#2

City

Miami

State/Province

Florida

ZIP/Postal Code

33176

Country

United States

Facility Name

Clinical Research Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33183

Country

United States

Facility Name

Clinical Research Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33467

Country

United States

Facility Name

Clinical Research Site

City

Naples

State/Province

Florida

ZIP/Postal Code

34102

Country

United States

Facility Name

Clinical Research Site

City

Oakland Park

State/Province

Florida

ZIP/Postal Code

33334

Country

United States

Facility Name

Clinical Research Site

City

Orlando

State/Province

Florida

ZIP/Postal Code

32819

Country

United States

Facility Name

Clinical Research Site

City

Ormond Beach

State/Province

Florida

ZIP/Postal Code

32174

Country

United States

Facility Name

Clinical Research Site

City

Palm Beach Gardens

State/Province

Florida

ZIP/Postal Code

33410

Country

United States

Facility Name

Clinical Research Site

City

Palmetto Bay

State/Province

Florida

ZIP/Postal Code

33157

Country

United States

Facility Name

Clinical Research Site#2

City

Pompano Beach

State/Province

Florida

ZIP/Postal Code

33064

Country

United States

Facility Name

Clinical Research Site

City

Saint Petersburg

State/Province

Florida

ZIP/Postal Code

33713

Country

United States

Facility Name

Clinical Research Site

City

Sarasota

State/Province

Florida

ZIP/Postal Code

34243

Country

United States

Facility Name

Clinical Research Site#1

City

Tampa

State/Province

Florida

ZIP/Postal Code

33609

Country

United States

Facility Name

Clinical Research Site#2

City

Tampa

State/Province

Florida

ZIP/Postal Code

33609

Country

United States

Facility Name

Clinical Research Site#2

City

Tampa

State/Province

Florida

ZIP/Postal Code

33613

Country

United States

Facility Name

Clinical Research Site

City

Tampa

State/Province

Florida

ZIP/Postal Code

33634

Country

United States

Facility Name

Clinical Research Site

City

The Villages

State/Province

Florida

ZIP/Postal Code

32162

Country

United States

Facility Name

Clinical Research Site

City

West Palm Beach

State/Province

Florida

ZIP/Postal Code

33407

Country

United States

Facility Name

Clinical Research Site

City

Winter Park

State/Province

Florida

ZIP/Postal Code

32789

Country

United States

Facility Name

Clinical Research Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30342

Country

United States

Facility Name

Clinical Research Site

City

Newnan

State/Province

Georgia

ZIP/Postal Code

30265

Country

United States

Facility Name

Clinical Research Site

City

Honolulu

State/Province

Hawaii

ZIP/Postal Code

96817

Country

United States

Facility Name

Clinical Research Site

City

Schaumburg

State/Province

Illinois

ZIP/Postal Code

60194

Country

United States

Facility Name

Clinical Research Site

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

Facility Name

Clinical Research Site

City

Lenexa

State/Province

Kansas

ZIP/Postal Code

66214

Country

United States

Facility Name

Clinical Research Site

City

Paducah

State/Province

Kentucky

ZIP/Postal Code

42003

Country

United States

Facility Name

Clinical Research Site

City

Bedford

State/Province

Massachusetts

ZIP/Postal Code

01730

Country

United States

Facility Name

Clinical Research Site

City

Quincy

State/Province

Massachusetts

ZIP/Postal Code

02169

Country

United States

Facility Name

Clinical Research Site

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48105

Country

United States

Facility Name

Clinical Research Site

City

Paw Paw

State/Province

Michigan

ZIP/Postal Code

49079

Country

United States

Facility Name

Clinical Research Site

City

Hattiesburg

State/Province

Mississippi

ZIP/Postal Code

39401

Country

United States

Facility Name

Clinical Research Site

City

Creve Coeur

State/Province

Missouri

ZIP/Postal Code

63141

Country

United States

Facility Name

Clinical Research Site

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63128

Country

United States

Facility Name

Clinical Research Site

City

Mount Arlington

State/Province

New Jersey

ZIP/Postal Code

07856

Country

United States

Facility Name

Clinical Research Site

City

Toms River

State/Province

New Jersey

ZIP/Postal Code

08755

Country

United States

Facility Name

Clinical Research Site

City

West Long Branch

State/Province

New Jersey

ZIP/Postal Code

07764

Country

United States

Facility Name

Clinical Research Site

City

Amherst

State/Province

New York

ZIP/Postal Code

14226

Country

United States

Facility Name

Clinical Research Site

City

Brooklyn

State/Province

New York

ZIP/Postal Code

11229

Country

United States

Facility Name

Clinical Research Site

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

Facility Name

Clinical Research Site

City

New York

State/Province

New York

ZIP/Postal Code

10036

Country

United States

Facility Name

Clinical Research Site

City

Orangeburg

State/Province

New York

ZIP/Postal Code

10962

Country

United States

Facility Name

Clinical Research Site

City

Rochester

State/Province

New York

ZIP/Postal Code

14620

Country

United States

Facility Name

Clinical Research Site

City

Staten Island

State/Province

New York

ZIP/Postal Code

10312

Country

United States

Facility Name

Clinical Research Site

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Facility Name

Clinical Research Site

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27157

Country

United States

Facility Name

Clinical Research Site

City

Akron

State/Province

Ohio

ZIP/Postal Code

44320

Country

United States

Facility Name

Clinical Research Site

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45219

Country

United States

Facility Name

Clinical Research Site#1

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43210

Country

United States

Facility Name

Clinical Research Site#2

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43210

Country

United States

Facility Name

Clinical Research Site

City

Dayton

State/Province

Ohio

ZIP/Postal Code

45459

Country

United States

Facility Name

Clinical Research Site

City

Westerville

State/Province

Ohio

ZIP/Postal Code

43082

Country

United States

Facility Name

Clinical Research Site

City

Edmond

State/Province

Oklahoma

ZIP/Postal Code

73012

Country

United States

Facility Name

Clinical Research Site

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73103

Country

United States

Facility Name

Clinical Research Site

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73106

Country

United States

Facility Name

Clinical Research Site

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73112

Country

United States

Facility Name

Clinical Research Site

City

Moosic

State/Province

Pennsylvania

ZIP/Postal Code

18507

Country

United States

Facility Name

Clinical Research Site

City

Willow Grove

State/Province

Pennsylvania

ZIP/Postal Code

19090

Country

United States

Facility Name

Clinical Research Site

City

East Providence

State/Province

Rhode Island

ZIP/Postal Code

02914

Country

United States

Facility Name

Clinical Research Site

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29401

Country

United States

Facility Name

Clinical Research Site#2

City

Cordova

State/Province

Tennessee

ZIP/Postal Code

38018

Country

United States

Facility Name

Clinical Research Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

Clinical Research Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75390-8898

Country

United States

Facility Name

Clinical Research Site

City

Irving

State/Province

Texas

ZIP/Postal Code

75062

Country

United States

Facility Name

Clinical Research Site

City

Mansfield

State/Province

Texas

ZIP/Postal Code

76063

Country

United States

Facility Name

Clinical Research Site

City

Clinton

State/Province

Utah

ZIP/Postal Code

84015

Country

United States

Facility Name

Clinical Research Site

City

Woodstock

State/Province

Vermont

ZIP/Postal Code

05091

Country

United States

Facility Name

Clinical Research Site#1

City

Tallinn

ZIP/Postal Code

11315

Country

Estonia

Facility Name

Clinical Research Site#2

City

Tallinn

ZIP/Postal Code

11315

Country

Estonia

Facility Name

Clinical Research Site

City

Tartu

ZIP/Postal Code

50406

Country

Estonia

Facility Name

Clinical Research Site

City

Mittweida

ZIP/Postal Code

9648

Country

Germany

Facility Name

Clinical Research Site

City

Lublin

State/Province

Lubelskie

ZIP/Postal Code

20-093

Country

Poland

Facility Name

Clinical Research Site

City

Bydgoszcz

ZIP/Postal Code

85-163

Country

Poland

Facility Name

Clinical Research Site

City

Kielce

ZIP/Postal Code

25-411

Country

Poland

Facility Name

Clinical Research Site

City

Lublin

ZIP/Postal Code

20-064

Country

Poland

Facility Name

Clinical Research Site

City

Poznan

ZIP/Postal Code

60-369

Country

Poland

Facility Name

Clinical Research Site

City

Poznan

ZIP/Postal Code

61-853

Country

Poland

Facility Name

Clinical Research Site

City

Pruszcz Gdanski

ZIP/Postal Code

83-000

Country

Poland

Facility Name

Clinical Research Site

City

Siemianowice Śląskie

ZIP/Postal Code

41-100

Country

Poland

Facility Name

Clinical Research Site

City

Torres Vedras

ZIP/Postal Code

2560-280

Country

Portugal

Facility Name

Clinical Research Site

City

Bayamon

ZIP/Postal Code

961

Country

Puerto Rico

Facility Name

Clinical Research Site

City

San Juan

ZIP/Postal Code

918

Country

Puerto Rico

12. IPD Sharing Statement

Learn more about this trial

Efficacy, Safety and Tolerability of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type

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Efficacy, Safety and Tolerability of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type

Agitation in Patients With Dementia of the Alzheimer's Type

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial