BAC in Patient With Alzheimer's Disease or Vascular Dementia

NCT ID: NCT02467413

Last Updated: 2022-10-07

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-30
• Study Completion Date: 2018-11-01

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.

Detailed Description

This study is 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.

Eligible patients will be randomly assigned to receive either one of topical application of BAC or BAC matched vehicle, topical application on external nasal skin, scalp, and neck, 30mL/day, 2 times daily.

The treatment duration for each patient is 12 weeks, which consists of 6 visits located at Screening, Baseline (Week 0), Weeks -2, -4, -8, and -12. During the treatment period, patients may continue to receive routinely used medications or treatments for Alzheimer's disease or vascular dementia except those prohibited under this protocol.

Conditions

Alzheimer's Disease; Vascular Dementia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

BAC treatment group

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

Group Type: ACTIVE_COMPARATOR

BAC

Intervention Type: DRUG

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

BAC Matched vehicle

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

Group Type: PLACEBO_COMPARATOR

BAC Matched Vehicle

Intervention Type: OTHER

BAC Matched Vehicle

Interventions

BAC

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

Intervention Type: DRUG

BAC Matched Vehicle

BAC Matched Vehicle

Intervention Type: OTHER

Other Intervention Names

CSTC1-BAC

Eligibility Criteria

Inclusion Criteria

A patient is eligible for the study if all of the following apply:

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)

4. Able to read, write, communicate, and understand cognitive testing instructions

5. 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

6. Signed, by patients and the responsible caregiver, the written informed consent form

Exclusion Criteria

1. With large-artery stroke (thrombotic stroke)

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. With history of stroke and hospitalized for stroke in the previous 3 months

7. With history of alcohol or drug abuse

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), or γ-glutamyl transferase (γ-GT) more than 2 times the upper limit of normal

9. With depression, not well-controlled with medications.

10. With any uncontrolled illness 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

13. Enrollment in any investigational drug trial within 4 weeks before entering this study

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

A2 Healthcare Taiwan Corporation

INDUSTRY

Sponsor Role: collaborator

Charsire Biotechnology Corp.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pai Ming-Chyi, PhD

Role: PRINCIPAL_INVESTIGATOR

Neurology National Cheng Kung University Hospital

Locations

National Cheng Kung University Hospital

Tainan City, , Taiwan

Countries

Taiwan

Other Identifiers

BAC-01

Identifier Type: -

Identifier Source: org_study_id