BAC in Patient With Alzheimer's Disease or Vascular Dementia

NCT02467413 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: BAC-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to evaluate the efficacy of BAC patients with Alzheimer's disease or vascular dementia.The secondary objective of this study is to evaluate the safety of BAC patients with Alzheimer's disease or vascular dementia.

Conditions

Alzheimer's Disease; Vascular Dementia

Keywords

Alzheimer's Disease; Vascular Dementia

Outcome Measures

Primary Outcomes (1)

• Change in Alzheimer's 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.

  Weeks 12

Secondary Outcomes (9)

• Change in ADAS-cog score at all post treatment visits (except Week-12 visit) compared to baseline

  Weeks 4, 8, 12

• Clinician's Interview Based Impression of Change-Plus Caregiver Input (CIBIC-plus) score at all post treatment visits

  Weeks 4, 8, 12

• Change in Activities of Daily Living (ADL) score at all post treatment visits compared to baseline

  Weeks 4, 8, 12

• Change in Mini-Mental State Examination (MMSE) score at all post treatment visits compared to baseline

  Weeks 4, 8, 12

• Change in Neuropsychiatric Inventory (NPI) score at all post treatment visits compared to baseline

  Weeks 4, 8, 12

Study Arms (2)

BAC treatment group

ACTIVE COMPARATOR

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

Drug: BAC

BAC Matched vehicle

PLACEBO COMPARATOR

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

Other: BAC Matched Vehicle

Interventions

BAC DRUG

(vapor fraction from seeds of Glycine max (L.) Merr. and composition thereof)

Also known as: CSTC1-BAC

BAC treatment group

BAC Matched Vehicle OTHER

BAC Matched Vehicle

BAC Matched vehicle

Eligibility Criteria

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

You may qualify if:

• A patient is eligible for the study if all of the following apply:
• 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)
• Able to read, write, communicate, and understand cognitive testing instructions
• Having a responsible caregiver who spends adequate time daily with the patient; the caregiver will accompany the patient to all clinic visits during the study and supervise all study dosing requirements and concomitant medications
• Signed, by patients and the responsible caregiver, the written informed consent form

You may not qualify if:

• With large-artery stroke (thrombotic stroke)
• 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
• With history of stroke and hospitalized for stroke in the previous 3 months
• With history of alcohol or drug abuse
• 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), or γ-glutamyl transferase (γ-GT) more than 2 times the upper limit of normal
• With depression, not well-controlled with medications.
• With any uncontrolled illness 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
• Enrollment in any investigational drug trial within 4 weeks before entering this study

Sponsors & Collaborators

• Charsire Biotechnology Corp.: lead
• A2 Healthcare Taiwan Corporation: collaborator

Study Sites (1)

National Cheng Kung University Hospital

Tainan, 704, Taiwan

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

Study Officials

• Pai Ming-Chyi, PhD

  Neurology National Cheng Kung University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 4, 2015
• First Posted: June 10, 2015
• Study Start: January 30, 2017
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: October 7, 2022

Record last verified: 2022-10

Locations

TW (1)