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Assessment of the 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
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
AVP-786
Placebo
Sponsored by
Otsuka Pharmaceutical Development & Commercialization, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

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 of the Alzheimer's type, Alzheimer's disease, AVP-786, Deudextromethorphan hydrobromide, Quinidine sulfate

Eligibility Criteria

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

Inclusion Criteria:

  • Participants with a diagnosis of probable Alzheimer's disease according to the 2011 Neuropsychiatric Inventory Agitation/Aggression (NPI-AA) working groups criteria
  • Participants with clinically significant, moderate-to-severe agitation for at least 2 weeks prior to Screening that interferes with daily routine per the Investigator's judgment
  • Participants who require pharmacotherapy for the treatment of agitation per the Investigator's judgment after an evaluation of reversible factors and a course of nonpharmacological interventions
  • Diagnosis of agitation must meet the International Psychogeriatric Association (IPA) provisional definition of agitation.
  • Participants meeting an additional predetermined blinded eligibility criterion, which will remain blinded to the clinical study site Investigators and staff
  • Participants with a reliable caregiver who is able and willing to comply with all study procedures, including adherence to administering study drug and not administering any prohibited medications during the course of the study, and who spends a minimum of 2 hours per day for 4 days per week with the participant

Exclusion Criteria:

  • Participants with dementia predominantly of the non-Alzheimer's type (e.g., vascular dementia, frontotemporal dementia, Parkinson's disease, substance-induced dementia)
  • Participants with symptoms of agitation that are not secondary to Alzheimer's dementia (e.g., secondary to pain, other psychiatric disorder, or delirium)
  • 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 [except skin basal-cell carcinoma], poorly controlled diabetes, poorly controlled hypertension, unstable pulmonary, renal or hepatic disease, unstable ischemic cardiac disease, dilated cardiomyopathy, or unstable valvular heart disease)
  • Participants with myasthenia gravis

Sites / Locations

  • Clinical Research SiteRecruiting
  • Clinical Research Site #840-081Recruiting
  • Clinical Research Site #840-013
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research SiteRecruiting
  • Clinical Research SiteRecruiting
  • Clinical Research Site #840-064Recruiting
  • Clinical Research SiteRecruiting
  • Clinical Research Site #840-056
  • Clinical Research SiteRecruiting
  • Clinical Research SiteRecruiting
  • Clinical Research SiteRecruiting
  • Clinical Research SiteRecruiting
  • Clinical Research Site #840-069Recruiting
  • Clinical Research SiteRecruiting
  • Clinical Research SiteRecruiting
  • Clinical Research Site
  • Clinical Research SiteRecruiting
  • Clinical Research SiteRecruiting
  • Clinical Research Site #840-041
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site #840-079Recruiting
  • Clinical Research Site #840-046
  • Clinical Research Site
  • Clinical Research Site # 840-001
  • Clinical Research Site #840-049Recruiting
  • Clinical Research SiteRecruiting
  • Clinical Research Site #840-033
  • Clinical Research SiteRecruiting
  • Clinical Research Site #840-072
  • Clinical Research Site #840-030
  • Clinical Research SiteRecruiting
  • Clinical Research Site #840-028
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site #840-061
  • Clinical Research Site
  • Clinical Research Site #840-018
  • Clinical Research SiteRecruiting
  • Clinical Research Site
  • Clinical Research Site #840-025
  • Clinical Research SiteRecruiting
  • Clinical Research SiteRecruiting
  • Clinical Research SiteRecruiting
  • Clinical Research Site # 208-001Recruiting
  • Clinical Research SiteRecruiting
  • Clinical Research Site #1Recruiting
  • Clinical Research Site #2Recruiting
  • Clinical Research SiteRecruiting
  • Clinical Research Site
  • Clinical Research Site #276-012Recruiting
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site #300-001Recruiting
  • Clinical Research Site# 300-005Recruiting
  • Clinical Research Site #300-002Recruiting
  • Clinical Research Site #300-003Recruiting
  • Clinical Research SiteRecruiting
  • Clinical Research SiteRecruiting
  • Clinical Research SiteRecruiting
  • Clinical Research SiteRecruiting
  • Clinical Research SiteRecruiting
  • Clinical Research Site #616-010Recruiting
  • Clinical Research SiteRecruiting
  • Clinical Research SiteRecruiting
  • Clinical Research SiteRecruiting
  • Clinical Research Site
  • Clinical Research SiteRecruiting
  • Clinical Research Site
  • Clinical Research SiteRecruiting
  • Clinical Research SiteRecruiting
  • Clinical Research SiteRecruiting
  • Clinical Research SiteRecruiting
  • Clinical Research Site #630-003Recruiting
  • Clinical Research SiteRecruiting
  • Clinical Research SiteRecruiting
  • Clinical Research SiteRecruiting
  • Clinical Research SiteRecruiting
  • Clinical Research SiteRecruiting
  • Clinical Research SiteRecruiting
  • Clinical Research Site
  • Clinical Research SiteRecruiting
  • Clinical Research SiteRecruiting
  • Clinical Research SiteRecruiting
  • Clinical Research Site# 826-006Recruiting
  • Clinical Research SiteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

AVP-786

Placebo

Arm Description

Participants will be assigned to treatment with AVP-786 capsules administered twice a day over a 12-week period.

Participants will be assigned to treatment with placebo capsules administered twice a day over a 12-week period.

Outcomes

Primary Outcome Measures

Change from Baseline to Week 12 in the Cohen-Mansfield Agitation Inventory (CMAI) Composite Score

Secondary Outcome Measures

Change from Baseline to Week 12 in the Clinical Global Impression of Severity of Illness (CGI-S) Score, as Related to Agitation

Full Information

First Posted
May 26, 2020
Last Updated
August 3, 2023
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04408755
Brief Title
Assessment of the 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 (Deudextromethorphan 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
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 8, 2020 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

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
No

5. Study Description

Brief Summary
This study will be conducted to evaluate the efficacy, safety, and tolerability of AVP-786 (deudextromethorphan hydrobromide [d6-DM]/quinidine sulfate [Q]) compared to placebo for the treatment of agitation in participants with dementia of the Alzheimer's type.
Detailed Description
Eligible participants for this study must have a diagnosis of probable Alzheimer's disease (AD) and must have clinically significant, moderate/severe agitation secondary to AD. This is a multicenter, randomized, double-blind, placebo-controlled study, consisting of 12 weeks of treatment. Approximately 750 participants will be enrolled at approximately 110 centers worldwide. Study medication will be administered orally twice-daily from Day 1 through Day 85. Screening will occur within approximately 4 weeks prior to randomization. Following screening procedures for assessment of inclusion and exclusion criteria, eligible participants will 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 of the Alzheimer's type, Alzheimer's disease, AVP-786, Deudextromethorphan hydrobromide, Quinidine sulfate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
750 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AVP-786
Arm Type
Experimental
Arm Description
Participants will be assigned to treatment with AVP-786 capsules administered twice a day over a 12-week period.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will be assigned to treatment with placebo capsules administered twice a day over a 12-week period.
Intervention Type
Drug
Intervention Name(s)
AVP-786
Intervention Description
oral capsules
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
oral capsules
Primary Outcome Measure Information:
Title
Change from Baseline to Week 12 in the Cohen-Mansfield Agitation Inventory (CMAI) Composite Score
Time Frame
Baseline; Week 12
Secondary Outcome Measure Information:
Title
Change from Baseline to Week 12 in the Clinical Global Impression of Severity of Illness (CGI-S) Score, as Related to Agitation
Time Frame
Baseline; Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants with a diagnosis of probable Alzheimer's disease according to the 2011 Neuropsychiatric Inventory Agitation/Aggression (NPI-AA) working groups criteria Participants with clinically significant, moderate-to-severe agitation for at least 2 weeks prior to Screening that interferes with daily routine per the Investigator's judgment Participants who require pharmacotherapy for the treatment of agitation per the Investigator's judgment after an evaluation of reversible factors and a course of nonpharmacological interventions Diagnosis of agitation must meet the International Psychogeriatric Association (IPA) provisional definition of agitation. Participants meeting an additional predetermined blinded eligibility criterion, which will remain blinded to the clinical study site Investigators and staff Participants with a reliable caregiver who is able and willing to comply with all study procedures, including adherence to administering study drug and not administering any prohibited medications during the course of the study, and who spends a minimum of 2 hours per day for 4 days per week with the participant Exclusion Criteria: Participants with dementia predominantly of the non-Alzheimer's type (e.g., vascular dementia, frontotemporal dementia, Parkinson's disease, substance-induced dementia) Participants with symptoms of agitation that are not secondary to Alzheimer's dementia (e.g., secondary to pain, other psychiatric disorder, or delirium) 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 [except skin basal-cell carcinoma], poorly controlled diabetes, poorly controlled hypertension, unstable pulmonary, renal or hepatic disease, unstable ischemic cardiac disease, dilated cardiomyopathy, or unstable valvular heart disease) Participants with myasthenia gravis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Otsuka Call Center
Phone
844-687-8522
Email
OtsukaRMReconciliation@rmpdc.org
Facility Information:
Facility Name
Clinical Research Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site #840-081
City
Fort Smith
State/Province
Arkansas
ZIP/Postal Code
72901
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site #840-013
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Clinical Research Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72209
Country
United States
Individual Site Status
Withdrawn
Facility Name
Clinical Research Site
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
Individual Site Status
Withdrawn
Facility Name
Clinical Research Site
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site #840-064
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33462
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site #840-056
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Clinical Research Site
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Doral
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34744
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site #840-069
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Individual Site Status
Withdrawn
Facility Name
Clinical Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33467
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32819
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site #840-041
City
Palm Beach Gardens
State/Province
Florida
ZIP/Postal Code
33410
Country
United States
Individual Site Status
Withdrawn
Facility Name
Clinical Research Site
City
Pompano Beach
State/Province
Florida
ZIP/Postal Code
33064
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Clinical Research Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Individual Site Status
Withdrawn
Facility Name
Clinical Research Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Individual Site Status
Withdrawn
Facility Name
Clinical Research Site #840-079
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site #840-046
City
Tampa
State/Province
Florida
ZIP/Postal Code
33634
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Clinical Research Site
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30265
Country
United States
Individual Site Status
Withdrawn
Facility Name
Clinical Research Site # 840-001
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817
Country
United States
Individual Site Status
Withdrawn
Facility Name
Clinical Research Site #840-049
City
Glen Burnie
State/Province
Maryland
ZIP/Postal Code
21061
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Hattiesburg
State/Province
Mississippi
ZIP/Postal Code
39401
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site #840-033
City
Mount Arlington
State/Province
New Jersey
ZIP/Postal Code
07856
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Clinical Research Site
City
West Long Branch
State/Province
New Jersey
ZIP/Postal Code
07764
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site #840-072
City
New Windsor
State/Province
New York
ZIP/Postal Code
12553
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Clinical Research Site #840-030
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Withdrawn
Facility Name
Clinical Research Site
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site #840-028
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Clinical Research Site
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45459
Country
United States
Individual Site Status
Withdrawn
Facility Name
Clinical Research Site
City
Westerville
State/Province
Ohio
ZIP/Postal Code
43082
Country
United States
Individual Site Status
Withdrawn
Facility Name
Clinical Research Site #840-061
City
Edmond
State/Province
Oklahoma
ZIP/Postal Code
73012
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Clinical Research Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73106
Country
United States
Individual Site Status
Withdrawn
Facility Name
Clinical Research Site #840-018
City
Moosic
State/Province
Pennsylvania
ZIP/Postal Code
18507
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Clinical Research Site
City
Cordova
State/Province
Tennessee
ZIP/Postal Code
38018
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77381
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Clinical Research Site #840-025
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23236
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Clinical Research Site
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Sofia
ZIP/Postal Code
1408
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Varna
ZIP/Postal Code
9020
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Clinical Research Site # 208-001
City
Aalborg
State/Province
Region Nordjylland
ZIP/Postal Code
9000
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Clinical Research Site #1
City
Tallinn
ZIP/Postal Code
11315
Country
Estonia
Individual Site Status
Recruiting
Facility Name
Clinical Research Site #2
City
Tallinn
ZIP/Postal Code
11315
Country
Estonia
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Tartu
ZIP/Postal Code
50406
Country
Estonia
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Bad Homburg Vor Der Höhe
State/Province
Hessen
ZIP/Postal Code
61348
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Clinical Research Site #276-012
City
Gera
State/Province
Thüringen
ZIP/Postal Code
935
Country
Germany
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Mittweida
ZIP/Postal Code
09648
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Clinical Research Site
City
Munich
ZIP/Postal Code
80336
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Clinical Research Site
City
Westerstede
ZIP/Postal Code
26655
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Clinical Research Site #300-001
City
Athens
ZIP/Postal Code
11528
Country
Greece
Individual Site Status
Recruiting
Facility Name
Clinical Research Site# 300-005
City
Athens
ZIP/Postal Code
15125
Country
Greece
Individual Site Status
Recruiting
Facility Name
Clinical Research Site #300-002
City
Maroúsi
ZIP/Postal Code
15123
Country
Greece
Individual Site Status
Recruiting
Facility Name
Clinical Research Site #300-003
City
Thessaloníki
ZIP/Postal Code
54645
Country
Greece
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Bydgoszcz
State/Province
Kujawsko-Pomorskie
ZIP/Postal Code
85-023
Country
Poland
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Lublin
State/Province
Lubelskie
ZIP/Postal Code
20-093
Country
Poland
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Bydgoszcz
ZIP/Postal Code
85-163
Country
Poland
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Kielce
ZIP/Postal Code
25-411
Country
Poland
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Lublin
ZIP/Postal Code
20-064
Country
Poland
Individual Site Status
Recruiting
Facility Name
Clinical Research Site #616-010
City
Lublin
ZIP/Postal Code
20-080
Country
Poland
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Poznan
ZIP/Postal Code
60-369
Country
Poland
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Poznan
ZIP/Postal Code
61-853
Country
Poland
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Pruszcz Gdanski
ZIP/Postal Code
83-000
Country
Poland
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Siemianowice Śląskie
ZIP/Postal Code
41-100
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Clinical Research Site
City
Warszawa
ZIP/Postal Code
01-737
Country
Poland
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Santa Maria Da Feira
State/Province
Aveiro
ZIP/Postal Code
4520-211
Country
Portugal
Individual Site Status
Withdrawn
Facility Name
Clinical Research Site
City
Braga
ZIP/Postal Code
4710-243
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Matosinhos
ZIP/Postal Code
4520-211
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Torres Vedras
ZIP/Postal Code
2560-280
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Bayamon
ZIP/Postal Code
00961
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Name
Clinical Research Site #630-003
City
Rio Piedras
ZIP/Postal Code
00935
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
San Juan
ZIP/Postal Code
00918
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Dnipro
ZIP/Postal Code
49005
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Kharkiv
ZIP/Postal Code
61068
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Kiev
ZIP/Postal Code
8631
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Kyiv
ZIP/Postal Code
04080
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Lviv
ZIP/Postal Code
79021
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Aylesbury
ZIP/Postal Code
HP18 0LX
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
Clinical Research Site
City
Blandford Forum
ZIP/Postal Code
DT11 7DD
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Crowborough
ZIP/Postal Code
TN61NY
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Fulwood
ZIP/Postal Code
PR2 9HT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Clinical Research Site# 826-006
City
Manchester
ZIP/Postal Code
M25 3BL
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Motherwell
ZIP/Postal Code
ML1 4UF
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing
IPD Sharing Time Frame
Data will be available after marketing approval in global markets or beginning 1-3 years following article publication. There is no end date to the availability of the data.
IPD Sharing Access Criteria
Otsuka will share data on the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/
IPD Sharing URL
https://clinical-trials.otsuka.com

Learn more about this trial

Assessment of the 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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