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A Study to Evaluate Efficacy and Safety of BAC in Patient With Alzheimer's Disease or Vascular Dementia

Primary Purpose

Alzheimer's Disease or Vascular Dementia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
BAC treatment
Matched vehicle
Sponsored by
Charsire Biotechnology Corp.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease or Vascular Dementia

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. With either gender aged at least 40 years old
  2. With a diagnosis of one of the following disease i. Vascular dementia according to the NINDS-AIREN International Workshop criteria or ii. Alzheimer's disease according to the NIAAA criteria iii. "Mixed" dementia (possible Alzheimer's disease with cerebrovascular disease) according to the NIAAA criteria

    Note:

    1. NINDS-AIREN: National Institute of Neurological Disorders and Stroke and Association Internationale pour la Recherche et l'Enseignement en Neurosciences
    2. NIAAA: National Institute on Aging-Alzheimer's Association
  3. With mild-to-moderate dementia (score of the Mini-Mental State Examination (MMSE) defined as between 10 to 24 and score of ADAS-Cog as at least 12)
  4. Able to read, write, communicate, and understand cognitive testing instructions
  5. Having a responsible caregiver who spends at least 4 hours daily with the patient. The caregiver will accompany the patient to all study visits, , supervise administration of study drug, and be able to assess the patient's condition
  6. Patients and the responsible caregiver willing and able to provide written informed consent form

Exclusion Criteria:

  1. With large vessel thrombosis (thrombotic stroke occurring in large arteries)
  2. With radiological evidence of other brain disorders (subdural hematoma, post-traumatic / post-surgery)
  3. With dementia caused by other brain diseases except Alzheimer's disease and vascular dementia (e.g. Parkinson's disease, demyelinated disease of the central nervous system, tumor, hydrocephalus, head injury, central nervous system infection including syphilis, acquired immune deficiency syndrome, etc.)
  4. With clinical evidence of pulmonary, hepatic, gastrointestinal, metabolic, endocrine or other life threatening diseases judged by investigators not suitable to enter the study
  5. With clinically unstable hypertension, diabetes mellitus, and cardiac disease for the last 3 months
  6. Ever hospitalized for stroke or with acute coronary syndrome in the previous 3 months prior to screening
  7. Drug or alcohol abuse within the previous 12 months of screening.
  8. With one of the following abnormal laboratory parameters: hemoglobin < 10 mg/dL or platelet < 100*109/L; creatinine or total bilirubin more than 1.5 times the upper limit value; alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphates (ALP), γ-glutamyl transferase (γ-GT) more than 2 times the upper limit of normal, or thyroid-stimulating hormone (TSH) more than 2.5 times the upper limit value or less than the lower limit value of normal
  9. With severe depression graded by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) and Cornell Scale for Depression in Dementia (CSDD)
  10. With any uncontrolled illness (including, but not limited to, any of the following: ongoing or active infection including hepatitis B, C, and HIV, active bleeding, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris or, cardiac arrhythmia) judged by the investigator that entering the trial may be detrimental to the patient
  11. With known or suspected hypersensitivity to any ingredients of study product and vehicle
  12. Pregnant or lactating or premenopausal with childbearing potential but not taking reliable contraceptive method(s) during the study period

    Note: Reliable contraceptive methods will consider as below:

    1. Established use of oral, injected or implanted hormonal methods of contraception > 3 months prior to baseline.
    2. Placement of an intrauterine device (IUD) or intrauterine system (IUS) > 3 months prior to baseline.
    3. Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository
    4. Partner male sterilization (i.e., vasectomy) > 1 month of screening
  13. Enrollment in any investigational drug trial within 4 weeks of screening visit
  14. Experienced dosage increment of routinely use in drugs listed as follows within past three months before Screening visit

    1. medications/treatments for Alzheimer's disease or vascular dementia
    2. antipsychotic medications including but not limited to selective serotonin reuptake inhibitors (SSRIs), benzodiazepine (BZD)
    3. Vitamin B12
    4. drugs for thyroid disease
  15. Current antiplatelet drug (antiaggregant) except dosage including but not limited to aspirin <= 100mg/day, clopidogrel <= 75mg/day, ticagrelor <= 180mg/day, dipyridamole <= 400mg/day
  16. Caregivers who have psychotic symptoms, are imminently suicidal, have an unstable medical condition (e.g. recent heart attack, recent stroke, episodes of dizziness, fainting attacks) or significant orthopaedic problems.

Sites / Locations

  • Clinical Research Consortium
  • Woodland International Research Group
  • Woodland Research Northwest, LLC
  • Pacific Research Network, LLC
  • NeuroTrials Research, Inc.
  • The Cognitive and Research Center of NJ
  • Advanced Memory Research Institute of NJ, PC
  • SPRI
  • Wake Research Associates
  • Neurology Diagnostics, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

BAC treatment

Matched vehicle

Arm Description

BAC, topical application on external nasal skin, scalp, and neck, 2 times daily, 30 g/day for 12 weeks

Matched vehicle, topical application on external nasal skin, scalp, and neck, 2 times daily, 30 g/day for 12 weeks

Outcomes

Primary Outcome Measures

Change in Alzheimer Disease Assessment Scale-cognitive (ADAS-cog) Score at Week 12 Visit Compared to Baseline
The Alzheimer's Disease Assessment Scale- Cognitive (ADAS-Cog) Subscale test is the standard assessment tool and one of the most popular cognitive testing instrument in clinical trials. It is designed to assess various cognitive abilities such as those associated with memory, language and praxis. It consists of 11 parts: 1. Word Recall Task; 2. Naming Task; 3: Commands; 4: Constructional Praxis; 5. Ideational Praxis; 6. Orientation; 7. Word Recognition Task; 8. Language; 9. Comprehension of Spoken Language; 10. Word Finding Difficulty; and 11. Remembering Test Instructions. Scores range from 0 to 70 with lower scores indicating lesser severity. ADAS-Cog was measured at Screening, Randomization/Baseline, Week 4, Week 8 and Week 12.

Secondary Outcome Measures

Change in ADAS-cog Score at All Post Treatment Visits (Except Week 12 Visit) Compared to Baseline
The Alzheimer's Disease Assessment Scale- Cognitive (ADAS-Cog) Subscale test is the standard assessment tool and one of the most popular cognitive testing instrument in clinical trials. It is designed to assess various cognitive abilities such as those associated with memory, language and praxis. It consists of 11 parts: 1. Word Recall Task; 2. Naming Task; 3: Commands; 4: Constructional Praxis; 5. Ideational Praxis; 6. Orientation; 7. Word Recognition Task; 8. Language; 9. Comprehension of Spoken Language; 10. Word Finding Difficulty; and 11. Remembering Test Instructions. Scores range from 0 to 70 with lower scores indicating lesser severity. ADAS-Cog was measured at Screening, Randomization/Baseline, Week 4, Week 8 and Week 12.
Clinician's Interview Based Impression of Change-Plus Caregiver Input (CIBIC-plus) Score at All Post Treatment Visits
This is a global measure of detectable change in cognition, function and behavior. The format for CIBIS/CIBIC-Plus consists of the assessment of an independent clinician based on observation of the patient at an interview, and information provided by the caregiver. The clinician's assessing severity at baseline and overall impression for assessing severity of the global change in disease severity, compared with baseline, is rated. The CIBIS/CIBIC plus examined general, cognitive, and behavioral function and activities of daily living on a 7-point categorical rating scale, ranging from a score of 0 indicating "Not assessed", to a score of 7 indicating "Among the most extremely ill patients" for CIBIS and ranging from 1 indicating "Very much improved", to a score of 7 indicating "Marked worsening", and with a score of 4 indicating "no change" for CIBIC-Plus. CIBIS was measured at Randomization visit and CIBIC-Plus was measured at Week 4, Week 8, and Week 12.
Change in Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Score at All Post Treatment Visits Compared to Baseline
An inventory of informant based items to assess activities of daily living and instrumental activities of daily living, i.e. functional performance, of Alzheimer's disease (AD). It consists of 23-item inventory of ADL, rated based on extent of assistance the patient requires (independently, with supervision, with physical help): 0 (total independence in performing an activity) to 4 (total inability to act independently). Each question varies in the number of options to choose. Total score range: 0 to 78; higher scores indicate less functional impairment. ADL will be measured at Randomization/Baseline, Week 4, Week 8, and Week 12.
Change in Mini-Mental State Examination (MMSE) Score at All Post Treatment Visits Compared to Baseline
This is a multi-item instrument that examines orientation, registration, attention, calculation, recall, visuospatial abilities and language. The score ranges from 0 to 30, with higher scores indicating better cognitive function. MMSE was measured at Screening, Randomization/Baseline, Week 4, Week 8, and Week 12.
Change in Neuropsychiatric Inventory (NPI) Score at All Post Treatment Visits Compared to Baseline: NPI-10 Frequency × Severity
The NPI is the behavior instrument most widely used in clinical trials of anti-dementia agents. The NPI uses a screening strategy to minimize administration time, examining and scoring only those behavioral domains with positive responses to screening questions. Both the frequency and the severity of each behavior are determined. Information for the NPI is obtained from a caregiver familiar with the patient's behavior. The NPI assesses 10 behavioral domains (10-item NPI, section A~J) common in dementia. Each NPI domain is scored by the caregiver based on a standardized interview administered by the clinician. Frequency is scored from 1 (occasionally) to 4 (very frequently) and severity is rated from 1 (mild) to 3 (severe). The score for each domain is frequency multiplied by severity. Therefore, the score ranges from 1 to 12 with higher scores indicate worse condition. NPI was measured at Randomization/Baseline, Week 4, Week 8, and Week 12.
Change in Neuropsychiatric Inventory (NPI) Score at All Post Treatment Visits Compared to Baseline: NPI-10 Caregiver Distress Score
The NPI is the behavior instrument most widely used in clinical trials of anti-dementia agents. The NPI uses a screening strategy to minimize administration time, examining and scoring only those behavioral domains with positive responses to screening questions. Both the frequency and the severity of each behavior are determined. Information for the NPI is obtained from a caregiver familiar with the patient's behavior. The NPI assesses 10 behavioral domains (10-item NPI) common in dementia. Each NPI domain is scored by the caregiver based on a standardized interview administered by the clinician. NPI-10 Caregiver Distress score is scored for associated caregiver distress from 0 (no distress) to 5 (very severe or extreme). Higher scores indicate greater distress. NPI was measured at Randomization/Baseline, Week 4, Week 8, and Week 12.
Change in Neuropsychiatric Inventory (NPI) Score at All Post Treatment Visits Compared to Baseline: NPI-12 Frequency × Severity Score
The NPI is the behavior instrument most widely used in clinical trials of anti-dementia agents. The NPI uses a screening strategy to minimize administration time, examining and scoring only those behavioral domains with positive responses to screening questions. Both the frequency and the severity of each behavior are determined. Information for the NPI is obtained from a caregiver familiar with the patient's behavior. The NPI assesses 12 behavioral domains (12-item NPI) common in dementia. Each NPI domain is scored by the caregiver based on a standardized interview administered by the clinician. Frequency is scored from 1 (occasionally) to 4 (very frequently) and severity is rated from 1 (mild) to 3 (severe). The score for each domain is frequency multiplied by severity. Therefore, the score ranges from 1 to 12 with higher scores indicate worse condition. NPI was measured at Randomization/Baseline, Week 4, Week 8, and Week 12.
Change in Neuropsychiatric Inventory (NPI) Score at All Post Treatment Visits Compared to Baseline: NPI-12 Caregiver Distress Score
The NPI is the behavior instrument most widely used in clinical trials of anti-dementia agents. The NPI uses a screening strategy to minimize administration time, examining and scoring only those behavioral domains with positive responses to screening questions. Both the frequency and the severity of each behavior are determined. Information for the NPI is obtained from a caregiver familiar with the patient's behavior. The NPI assesses 12 behavioral domains (12-item NPI) common in dementia. Each NPI domain is scored by the caregiver based on a standardized interview administered by the clinician. NPI-12 Caregiver Distress score is scored for associated caregiver distress from 0 (no distress) to 5 (very severe or extreme). Higher scores indicate greater distress. NPI was measured at Randomization/Baseline, Week 4, Week 8, and Week 12.
Number of Participants With Adverse Events
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a study medication and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a study medication, whether or not related to the study medication. Laboratory abnormalities should not be recorded as AEs unless determined to be clinically significant by the Investigator. The number of participants with adverse events within the BAC and placebo groups was determined.

Full Information

First Posted
August 29, 2016
Last Updated
October 5, 2022
Sponsor
Charsire Biotechnology Corp.
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1. Study Identification

Unique Protocol Identification Number
NCT02886494
Brief Title
A Study to Evaluate Efficacy and Safety of BAC in Patient With Alzheimer's Disease or Vascular Dementia
Official Title
A Randomized, Double-Blind, Vehicle-Controlled, Parallel, Phase II Study to Evaluate Efficacy and Safety of BAC in Patient With Alzheimer's Disease or Vascular Dementia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
December 2016 (Actual)
Primary Completion Date
November 1, 2018 (Actual)
Study Completion Date
November 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Charsire Biotechnology Corp.

4. Oversight

Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
A Randomized, Double-Blind, Vehicle-Controlled, Parallel, Phase II Study to Evaluate Efficacy and Safety of BAC in Patient with Alzheimer's Disease or Vascular Dementia
Detailed Description
This study was designed as a randomized, double-blind, vehicle-controlled and parallel trial to evaluate the efficacy and safety of BAC in patients with Alzheimer's disease or vascular dementia. The investigation product, BAC, is a potential anti-inflammatory agent consisted of Multi-Glycan Complex (MGC) from the Soybean extract. It aims to reduce the neruoinflammation in the Alzhemimer's disease and vascular dementia. In each study site, eligible patients were randomized and stratified to 1 of 2 dementia types (Alzheimer's disease and non-Alzheimer's disease) in 3:1 ratio to receive either one of topical application of BAC or BAC matched vehicle, topical application on external nasal skin, scalp, and neck, 2 times daily, 30 g/day. The treatment duration for each patient was 12 weeks, which consisted of 6 visits located at Screening (within 2 weeks before Baseline visit), Baseline (Week 0), Weeks 2, 4, 8, and Week 12 (Final). During the treatment period, patients may continue to receive medications or treatments routinely used for Alzheimer's disease or vascular dementia except those prohibited under this protocol.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease or Vascular Dementia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BAC treatment
Arm Type
Active Comparator
Arm Description
BAC, topical application on external nasal skin, scalp, and neck, 2 times daily, 30 g/day for 12 weeks
Arm Title
Matched vehicle
Arm Type
Placebo Comparator
Arm Description
Matched vehicle, topical application on external nasal skin, scalp, and neck, 2 times daily, 30 g/day for 12 weeks
Intervention Type
Drug
Intervention Name(s)
BAC treatment
Other Intervention Name(s)
CSTC1-BAC
Intervention Description
BAC, topical application on external nasal skin, scalp, and neck, 2 times daily, 30 g/day for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Matched vehicle
Other Intervention Name(s)
Placebo control
Intervention Description
BAC matched vehicle, topical application on external nasal skin, scalp, and neck, 2 times daily, 30 g/day for 12 weeks
Primary Outcome Measure Information:
Title
Change in Alzheimer Disease Assessment Scale-cognitive (ADAS-cog) Score at Week 12 Visit Compared to Baseline
Description
The Alzheimer's Disease Assessment Scale- Cognitive (ADAS-Cog) Subscale test is the standard assessment tool and one of the most popular cognitive testing instrument in clinical trials. It is designed to assess various cognitive abilities such as those associated with memory, language and praxis. It consists of 11 parts: 1. Word Recall Task; 2. Naming Task; 3: Commands; 4: Constructional Praxis; 5. Ideational Praxis; 6. Orientation; 7. Word Recognition Task; 8. Language; 9. Comprehension of Spoken Language; 10. Word Finding Difficulty; and 11. Remembering Test Instructions. Scores range from 0 to 70 with lower scores indicating lesser severity. ADAS-Cog was measured at Screening, Randomization/Baseline, Week 4, Week 8 and Week 12.
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Change in ADAS-cog Score at All Post Treatment Visits (Except Week 12 Visit) Compared to Baseline
Description
The Alzheimer's Disease Assessment Scale- Cognitive (ADAS-Cog) Subscale test is the standard assessment tool and one of the most popular cognitive testing instrument in clinical trials. It is designed to assess various cognitive abilities such as those associated with memory, language and praxis. It consists of 11 parts: 1. Word Recall Task; 2. Naming Task; 3: Commands; 4: Constructional Praxis; 5. Ideational Praxis; 6. Orientation; 7. Word Recognition Task; 8. Language; 9. Comprehension of Spoken Language; 10. Word Finding Difficulty; and 11. Remembering Test Instructions. Scores range from 0 to 70 with lower scores indicating lesser severity. ADAS-Cog was measured at Screening, Randomization/Baseline, Week 4, Week 8 and Week 12.
Time Frame
Week 4, 8
Title
Clinician's Interview Based Impression of Change-Plus Caregiver Input (CIBIC-plus) Score at All Post Treatment Visits
Description
This is a global measure of detectable change in cognition, function and behavior. The format for CIBIS/CIBIC-Plus consists of the assessment of an independent clinician based on observation of the patient at an interview, and information provided by the caregiver. The clinician's assessing severity at baseline and overall impression for assessing severity of the global change in disease severity, compared with baseline, is rated. The CIBIS/CIBIC plus examined general, cognitive, and behavioral function and activities of daily living on a 7-point categorical rating scale, ranging from a score of 0 indicating "Not assessed", to a score of 7 indicating "Among the most extremely ill patients" for CIBIS and ranging from 1 indicating "Very much improved", to a score of 7 indicating "Marked worsening", and with a score of 4 indicating "no change" for CIBIC-Plus. CIBIS was measured at Randomization visit and CIBIC-Plus was measured at Week 4, Week 8, and Week 12.
Time Frame
Week 4, 8, 12
Title
Change in Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Score at All Post Treatment Visits Compared to Baseline
Description
An inventory of informant based items to assess activities of daily living and instrumental activities of daily living, i.e. functional performance, of Alzheimer's disease (AD). It consists of 23-item inventory of ADL, rated based on extent of assistance the patient requires (independently, with supervision, with physical help): 0 (total independence in performing an activity) to 4 (total inability to act independently). Each question varies in the number of options to choose. Total score range: 0 to 78; higher scores indicate less functional impairment. ADL will be measured at Randomization/Baseline, Week 4, Week 8, and Week 12.
Time Frame
Week 4, 8, 12
Title
Change in Mini-Mental State Examination (MMSE) Score at All Post Treatment Visits Compared to Baseline
Description
This is a multi-item instrument that examines orientation, registration, attention, calculation, recall, visuospatial abilities and language. The score ranges from 0 to 30, with higher scores indicating better cognitive function. MMSE was measured at Screening, Randomization/Baseline, Week 4, Week 8, and Week 12.
Time Frame
Week 4, 8, 12
Title
Change in Neuropsychiatric Inventory (NPI) Score at All Post Treatment Visits Compared to Baseline: NPI-10 Frequency × Severity
Description
The NPI is the behavior instrument most widely used in clinical trials of anti-dementia agents. The NPI uses a screening strategy to minimize administration time, examining and scoring only those behavioral domains with positive responses to screening questions. Both the frequency and the severity of each behavior are determined. Information for the NPI is obtained from a caregiver familiar with the patient's behavior. The NPI assesses 10 behavioral domains (10-item NPI, section A~J) common in dementia. Each NPI domain is scored by the caregiver based on a standardized interview administered by the clinician. Frequency is scored from 1 (occasionally) to 4 (very frequently) and severity is rated from 1 (mild) to 3 (severe). The score for each domain is frequency multiplied by severity. Therefore, the score ranges from 1 to 12 with higher scores indicate worse condition. NPI was measured at Randomization/Baseline, Week 4, Week 8, and Week 12.
Time Frame
Week 4, 8, 12
Title
Change in Neuropsychiatric Inventory (NPI) Score at All Post Treatment Visits Compared to Baseline: NPI-10 Caregiver Distress Score
Description
The NPI is the behavior instrument most widely used in clinical trials of anti-dementia agents. The NPI uses a screening strategy to minimize administration time, examining and scoring only those behavioral domains with positive responses to screening questions. Both the frequency and the severity of each behavior are determined. Information for the NPI is obtained from a caregiver familiar with the patient's behavior. The NPI assesses 10 behavioral domains (10-item NPI) common in dementia. Each NPI domain is scored by the caregiver based on a standardized interview administered by the clinician. NPI-10 Caregiver Distress score is scored for associated caregiver distress from 0 (no distress) to 5 (very severe or extreme). Higher scores indicate greater distress. NPI was measured at Randomization/Baseline, Week 4, Week 8, and Week 12.
Time Frame
Week 4, 8, 12
Title
Change in Neuropsychiatric Inventory (NPI) Score at All Post Treatment Visits Compared to Baseline: NPI-12 Frequency × Severity Score
Description
The NPI is the behavior instrument most widely used in clinical trials of anti-dementia agents. The NPI uses a screening strategy to minimize administration time, examining and scoring only those behavioral domains with positive responses to screening questions. Both the frequency and the severity of each behavior are determined. Information for the NPI is obtained from a caregiver familiar with the patient's behavior. The NPI assesses 12 behavioral domains (12-item NPI) common in dementia. Each NPI domain is scored by the caregiver based on a standardized interview administered by the clinician. Frequency is scored from 1 (occasionally) to 4 (very frequently) and severity is rated from 1 (mild) to 3 (severe). The score for each domain is frequency multiplied by severity. Therefore, the score ranges from 1 to 12 with higher scores indicate worse condition. NPI was measured at Randomization/Baseline, Week 4, Week 8, and Week 12.
Time Frame
Week 4, 8, 12
Title
Change in Neuropsychiatric Inventory (NPI) Score at All Post Treatment Visits Compared to Baseline: NPI-12 Caregiver Distress Score
Description
The NPI is the behavior instrument most widely used in clinical trials of anti-dementia agents. The NPI uses a screening strategy to minimize administration time, examining and scoring only those behavioral domains with positive responses to screening questions. Both the frequency and the severity of each behavior are determined. Information for the NPI is obtained from a caregiver familiar with the patient's behavior. The NPI assesses 12 behavioral domains (12-item NPI) common in dementia. Each NPI domain is scored by the caregiver based on a standardized interview administered by the clinician. NPI-12 Caregiver Distress score is scored for associated caregiver distress from 0 (no distress) to 5 (very severe or extreme). Higher scores indicate greater distress. NPI was measured at Randomization/Baseline, Week 4, Week 8, and Week 12.
Time Frame
Week 4, 8, 12
Title
Number of Participants With Adverse Events
Description
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a study medication and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a study medication, whether or not related to the study medication. Laboratory abnormalities should not be recorded as AEs unless determined to be clinically significant by the Investigator. The number of participants with adverse events within the BAC and placebo groups was determined.
Time Frame
AEs were reported through the study completion (up to 12 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: With either gender aged at least 40 years old With a diagnosis of one of the following disease i. Vascular dementia according to the NINDS-AIREN International Workshop criteria or ii. Alzheimer's disease according to the NIAAA criteria iii. "Mixed" dementia (possible Alzheimer's disease with cerebrovascular disease) according to the NIAAA criteria Note: NINDS-AIREN: National Institute of Neurological Disorders and Stroke and Association Internationale pour la Recherche et l'Enseignement en Neurosciences NIAAA: National Institute on Aging-Alzheimer's Association With mild-to-moderate dementia (score of the Mini-Mental State Examination (MMSE) defined as between 10 to 24 and score of ADAS-Cog as at least 12) Able to read, write, communicate, and understand cognitive testing instructions Having a responsible caregiver who spends at least 4 hours daily with the patient. The caregiver will accompany the patient to all study visits, , supervise administration of study drug, and be able to assess the patient's condition Patients and the responsible caregiver willing and able to provide written informed consent form Exclusion Criteria: With large vessel thrombosis (thrombotic stroke occurring in large arteries) With radiological evidence of other brain disorders (subdural hematoma, post-traumatic / post-surgery) With dementia caused by other brain diseases except Alzheimer's disease and vascular dementia (e.g. Parkinson's disease, demyelinated disease of the central nervous system, tumor, hydrocephalus, head injury, central nervous system infection including syphilis, acquired immune deficiency syndrome, etc.) With clinical evidence of pulmonary, hepatic, gastrointestinal, metabolic, endocrine or other life threatening diseases judged by investigators not suitable to enter the study With clinically unstable hypertension, diabetes mellitus, and cardiac disease for the last 3 months Ever hospitalized for stroke or with acute coronary syndrome in the previous 3 months prior to screening Drug or alcohol abuse within the previous 12 months of screening. With one of the following abnormal laboratory parameters: hemoglobin < 10 mg/dL or platelet < 100*109/L; creatinine or total bilirubin more than 1.5 times the upper limit value; alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphates (ALP), γ-glutamyl transferase (γ-GT) more than 2 times the upper limit of normal, or thyroid-stimulating hormone (TSH) more than 2.5 times the upper limit value or less than the lower limit value of normal With severe depression graded by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) and Cornell Scale for Depression in Dementia (CSDD) With any uncontrolled illness (including, but not limited to, any of the following: ongoing or active infection including hepatitis B, C, and HIV, active bleeding, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris or, cardiac arrhythmia) judged by the investigator that entering the trial may be detrimental to the patient With known or suspected hypersensitivity to any ingredients of study product and vehicle Pregnant or lactating or premenopausal with childbearing potential but not taking reliable contraceptive method(s) during the study period Note: Reliable contraceptive methods will consider as below: Established use of oral, injected or implanted hormonal methods of contraception > 3 months prior to baseline. Placement of an intrauterine device (IUD) or intrauterine system (IUS) > 3 months prior to baseline. Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository Partner male sterilization (i.e., vasectomy) > 1 month of screening Enrollment in any investigational drug trial within 4 weeks of screening visit Experienced dosage increment of routinely use in drugs listed as follows within past three months before Screening visit medications/treatments for Alzheimer's disease or vascular dementia antipsychotic medications including but not limited to selective serotonin reuptake inhibitors (SSRIs), benzodiazepine (BZD) Vitamin B12 drugs for thyroid disease Current antiplatelet drug (antiaggregant) except dosage including but not limited to aspirin <= 100mg/day, clopidogrel <= 75mg/day, ticagrelor <= 180mg/day, dipyridamole <= 400mg/day Caregivers who have psychotic symptoms, are imminently suicidal, have an unstable medical condition (e.g. recent heart attack, recent stroke, episodes of dizziness, fainting attacks) or significant orthopaedic problems.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Thein
Organizational Affiliation
Pacific Research Network
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Research Consortium
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85283
Country
United States
Facility Name
Woodland International Research Group
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Woodland Research Northwest, LLC
City
Rogers
State/Province
Arkansas
ZIP/Postal Code
72758
Country
United States
Facility Name
Pacific Research Network, LLC
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
NeuroTrials Research, Inc.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
The Cognitive and Research Center of NJ
City
Springfield
State/Province
New Jersey
ZIP/Postal Code
07081
Country
United States
Facility Name
Advanced Memory Research Institute of NJ, PC
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
SPRI
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States
Facility Name
Wake Research Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Neurology Diagnostics, Inc.
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45459
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Study to Evaluate Efficacy and Safety of BAC in Patient With Alzheimer's Disease or Vascular Dementia

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