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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02886494
Recruitment Status : Completed
First Posted : September 1, 2016
Last Update Posted : July 30, 2019
Information provided by (Responsible Party):
Charsire Biotechnology Corp.

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

Condition or disease Intervention/treatment Phase
Alzheimer's Disease or Vascular Dementia Drug: BAC Drug: Matched placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : December 2016
Actual Primary Completion Date : November 1, 2018
Actual Study Completion Date : November 1, 2018

Arm Intervention/treatment
Active Comparator: BAC Drug: BAC
Placebo Comparator: Matched vehicle Drug: Matched placebo

Primary Outcome Measures :
  1. Change in Alzheimer Disease Assessment Scale-cognitive (ADAS-cog) score at Week 12 visit compared to baseline [ Time Frame: Week 12 ]

Secondary Outcome Measures :
  1. Change in ADAS-cog score at all post treatment visits (except Week 12 visit) compared to baseline [ Time Frame: Week 4, 8 ]
  2. Clinician's Interview Based Impression of Change-Plus Caregiver Input (CIBIC-plus) score at all post treatment visits [ Time Frame: Week 4, 8, 12 ]
  3. Change in Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) score at all post treatment visits compared to baseline [ Time Frame: Week 4, 8, 12 ]
  4. Change in Mini-Mental State Examination (MMSE) score at all post treatment visits compared to baseline [ Time Frame: Week 4, 8, 12 ]
  5. Change in Neuropsychiatric Inventory (NPI) score at all post treatment visits compared to baseline [ Time Frame: Week 4, 8, 12 ]
  6. Adverse event incidence [ Time Frame: Week 4, 8, 12 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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


    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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02886494

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United States, Arizona
Clinical Research Consortium
Tempe, Arizona, United States, 85283
United States, Arkansas
Woodland International Research Group
Little Rock, Arkansas, United States, 72211
Woodland Research Northwest, LLC
Rogers, Arkansas, United States, 72758
United States, California
Pacific Research Network, LLC
San Diego, California, United States, 92103
United States, Georgia
NeuroTrials Research, Inc.
Atlanta, Georgia, United States, 30342
United States, New Jersey
The Cognitive and Research Center of NJ
Springfield, New Jersey, United States, 07081
Advanced Memory Research Institute of NJ, PC
Toms River, New Jersey, United States, 08755
United States, New York
Brooklyn, New York, United States, 11235
United States, North Carolina
Wake Research Associates
Raleigh, North Carolina, United States, 27612
United States, Ohio
Neurology Diagnostics, Inc.
Dayton, Ohio, United States, 45459
Sponsors and Collaborators
Charsire Biotechnology Corp.

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Responsible Party: Charsire Biotechnology Corp. Identifier: NCT02886494     History of Changes
Other Study ID Numbers: BAC-02
First Posted: September 1, 2016    Key Record Dates
Last Update Posted: July 30, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia, Vascular
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cerebrovascular Disorders
Intracranial Arteriosclerosis
Intracranial Arterial Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases