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



Status:Recruiting
Conditions:Alzheimer Disease, Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:40 - Any
Updated:4/17/2018
Start Date:December 2016
End Date:November 2019

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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

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


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.
We found this trial at
10
sites
Little Rock, Arkansas 72211
Principal Investigator: George Konis, MD
Phone: 501-221-8681
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1100 Johnson Ferry Road
Atlanta, Georgia 30342
404-851-9934
Principal Investigator: Dennis M Lacey, MD
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Brooklyn, New York 11235
Principal Investigator: Evgeny Fink, MD
Phone: 718-616-2249
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Dayton, Ohio 45414
Principal Investigator: Joel Vandersluis, MD
Phone: 937-224-8200
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3100 Duraleigh Rd
Raleigh, North Carolina 27612
(919) 781-2514
Principal Investigator: Singar Jagadeesan, MD
Phone: 919-781-2514
Wake Research Associates, LLC Wake Research is an Organization of Unified Investigational Sites working closely...
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609 West Dyke Road
Rogers, Arkansas 72758
Principal Investigator: Fayz Hudefi, MD
Phone: 479-927-3000
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San Diego, California 92103
Principal Investigator: Stephen Thein, PhD
Phone: 619-294-4302
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Springfield, New Jersey 07081
Principal Investigator: Michelle Papka, PhD
Phone: 973-850-4622
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Tempe, Arizona 85283
Principal Investigator: Corey Anderson, MD
Phone: 602-910-3343
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Tempe, AZ
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Toms River, New Jersey 08757
Principal Investigator: Sanjiv Sharma, MD
Phone: 732-341-9500
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