WithdrawnNCT02467413Updated May 20, 2026

BAC in Patient With Alzheimer's Disease or Vascular Dementia

A Phase 2 interventional study of BAC and BAC Matched Vehicle in Alzheimer's Disease and Vascular Dementia, sponsored by Botanicure Co., Ltd.. Withdrawn at 1 site in Taiwan. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-05-20.

Sponsored by Botanicure Co., Ltd. · Phase 2, Interventional, and Treatment

Why this study was withdrawn

The study was withdrawn before participants were enrolled.

Phase: Phase 2
Study type: Interventional
Enrollment: 0
Allocation: Randomized
Ages: 40 Years and older
Sex: All

Study 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.

Read the 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 studied

Alzheimer's Disease
Vascular Dementia

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Keywords

Alzheimer's Disease
Vascular Dementia

In context

Alzheimer Disease

3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.

Browse Alzheimer Disease studies →

Lead sponsor

This is the only study on the registry with Botanicure Co., Ltd. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 40 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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:
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
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

Exclusion criteria

Exclusion Criteria:

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

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 0 participants (actual)

Study arms

Active comparator
BAC treatment group
BAC, topical application on external nasal skin, scalp, and neck, 30g/day, 2 times daily, for 12 weeks
Drug: BAC
Placebo comparator
BAC Matched vehicle
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

DrugBAC
(vapor fraction from seeds of Glycine max (L.) Merr. and composition thereof)
Also known as: CSTC1-BAC
OtherBAC Matched Vehicle
BAC Matched Vehicle

What researchers measure

Primary outcomes

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.
Time frame: Weeks 12

Secondary outcomes

Change in ADAS-cog score at all post treatment visits (except 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.
Time frame: Weeks 4, 8, 12
Clinician's Interview Based Impression of Change-Plus Caregiver Input (CIBIC-plus) score at all post treatment visits
This is a global measure of detectable change in cognition, function and behavior.
Time frame: Weeks 4, 8, 12
Change in Activities of Daily Living (ADL) score at all post treatment visits compared to baseline
An inventory of informant based items to assess activities of daily living and instrumental activities of daily living, i.e. functional performance, of Alzheimer's disease (AD).
Time frame: Weeks 4, 8, 12
Change in Mini-Mental State Examination (MMSE) score at all post treatment visits compared to baseline
This is a multi-item instrument that examines orientation, registration, attention, calculation, recall, visuospatial abilities and language. The score ranges from 0 to 30, with higher scores indicating better cognitive function. MMSE was measured at Screening, Randomization/Baseline, Week 4, Week 8, and Week 12.
Time frame: Weeks 4, 8, 12
Change in Neuropsychiatric Inventory (NPI) score at all post treatment visits compared to baseline
The NPI is the behavior instrument most widely used in clinical trials of anti-dementia agents. The NPI uses a screening strategy to minimize administration time, examining and scoring only those behavioral domains with positive responses to screening questions. Both the frequency and the severity of each behavior are determined. Information for the NPI is obtained from a caregiver familiar with the patient's behavior. The NPI assesses 12 behavioral domains (12-item NPI) common in dementia. Each NPI domain is scored by the caregiver based on a standardized interview administered by the clinician. NPI-12 Caregiver Distress score is scored for associated caregiver distress from 0 (no distress) to 5 (very severe or extreme). Higher scores indicate greater distress. NPI was measured at Randomization/Baseline, Week 4, Week 8, and Week 12.
Time frame: Weeks 4, 8, 12
Adverse event incidence
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a study medication and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a study medication, whether or not related to the study medication. Laboratory abnormalities should not be recorded as AEs unless determined to be clinically significant by the Investigator. The number of participants with adverse events within the BAC and placebo groups was determined.
Time frame: Baseline, Weeks 4, 8, 12
Change in physical examination results
Items include general appearance, skin, eyes, ears, nose, throat, head and neck, heart, joints, chest and lungs, abdomen, lymph nodes, musculoskeletal, nervous system, and others.
Time frame: Weeks 4, 8, 12
Net change from baseline in laboratory test results
Items include blood pressures, pulse rate, respiratory rate, and body temperature.
Time frame: Weeks 4, 8, 12
Net change from baseline in vital signs
Items include 1. hematology: hemoglobin, hematocrit, red blood cell (RBC), platelet, white blood cell (WBC) with differential counts; 2. Biochemistry: aspartate aminotransferase (AST), alanine aminotransferase (ALT), γ-glutamyl transferase (γ-GT), serum creatinine, blood urea nitrogen (BUN), albumin, total protein, alkaline phosphatase, total bilirubin
Time frame: Weeks 4, 8, 12]

Study locations

1 site

National Cheng Kung University Hospital
Tainan, 704, Taiwan

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02467413
Lead sponsor: Botanicure Co., Ltd.
Collaborators: A2 Healthcare Taiwan Corporation
Responsible party: Sponsor
First posted: Jun 10, 2015
Start date: Jan 30, 2017 (estimated)
Primary completion: Nov 1, 2018 (estimated)
Completion: Nov 1, 2018 (estimated)
Last update: May 20, 2026

Study contacts

Pai Ming-Chyi, PhD

principal investigator · Neurology National Cheng Kung University Hospital

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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