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

NCT02886494 | Completed Phase 2 Results

• 1 other identifier: BAC-02
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 10

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

Conditions

Alzheimer's Disease or Vascular Dementia

Outcome Measures

Primary Outcomes (1)

• 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.

  Week 12

Secondary Outcomes (9)

• Change in ADAS-cog Score at All Post Treatment Visits (Except Week 12 Visit) Compared to Baseline

  Week 4, 8

• Clinician's Interview Based Impression of Change-Plus Caregiver Input (CIBIC-plus) Score at All Post Treatment Visits

  Week 4, 8, 12

• Change in Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Score at All Post Treatment Visits Compared to Baseline

  Week 4, 8, 12

• Change in Mini-Mental State Examination (MMSE) Score at All Post Treatment Visits Compared to Baseline

  Week 4, 8, 12

• Change in Neuropsychiatric Inventory (NPI) Score at All Post Treatment Visits Compared to Baseline: NPI-10 Frequency × Severity

  Week 4, 8, 12

Study Arms (2)

BAC treatment

ACTIVE COMPARATOR

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

Drug: BAC treatment

Matched vehicle

PLACEBO COMPARATOR

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

Drug: Matched vehicle

Interventions

BAC treatment DRUG

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

Also known as: CSTC1-BAC

BAC treatment

Matched vehicle DRUG

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

Also known as: Placebo control

Matched vehicle

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Charsire Biotechnology Corp.: lead

Study Sites (10)

Clinical Research Consortium

Tempe, Arizona, 85283, United States

Location

Woodland International Research Group

Little Rock, Arkansas, 72211, United States

Location

Woodland Research Northwest, LLC

Rogers, Arkansas, 72758, United States

Location

Pacific Research Network, LLC

San Diego, California, 92103, United States

Location

NeuroTrials Research, Inc.

Atlanta, Georgia, 30342, United States

Location

The Cognitive and Research Center of NJ

Springfield, New Jersey, 07081, United States

Location

Advanced Memory Research Institute of NJ, PC

Toms River, New Jersey, 08755, United States

Location

SPRI

Brooklyn, New York, 11235, United States

Location

Wake Research Associates

Raleigh, North Carolina, 27612, United States

Location

Neurology Diagnostics, Inc.

Dayton, Ohio, 45459, United States

Location

MeSH Terms

Conditions

Alzheimer Disease; Dementia, Vascular

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cerebrovascular Disorders; Intracranial Arteriosclerosis; Intracranial Arterial Diseases; Leukoencephalopathies; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: R&D associate
• Organization: Charsire Biotechnology Corp.

cs42@charsire.com

+886-6-702-0817

Study Officials

• Stephen Thein

  Pacific Research Network

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2016
• First Posted: September 1, 2016
• Study Start: December 1, 2016
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: October 13, 2022
• Results First Posted: July 19, 2021

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)