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A Study to Evaluate Efficacy and Safety of BAC in Patient With Alzheimer's Disease or Vascular Dementia | Clinical Trials | Clareo Health

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A 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

NCT02886494•Charsire Biotechnology Corp.

View on ClinicalTrials.gov

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.

Eligibility

Age

40 - No limit years

Sex

ALL

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
+15 more criteria

Locations (10)

Clinical Research Consortium

Tempe, Arizona, United States

Woodland International Research Group

Little Rock, Arkansas, United States

Woodland Research Northwest, LLC

Rogers, Arkansas, United States

Pacific Research Network, LLC

San Diego, California, United States

NeuroTrials Research, Inc.

Atlanta, Georgia, United States

The Cognitive and Research Center of NJ

Springfield, New Jersey, United States

Advanced Memory Research Institute of NJ, PC

Toms River, New Jersey, United States

SPRI

Brooklyn, New York, United States

Wake Research Associates

Raleigh, North Carolina, United States

Neurology Diagnostics, Inc.

Dayton, Ohio, United States

Key Dates

Start Date

December 1, 2016

Primary Completion Date

November 1, 2018

Completion Date

November 1, 2018

Last Updated

October 13, 2022

Enrollment

ACTUAL participants

Conditions

Alzheimer's Disease or Vascular Dementia

Interventions

BAC treatment

DRUG

Matched vehicle

DRUG