Alzheimer's DiseasePhase 2NCT02467413
BAC in Patient With Alzheimer's Disease or Vascular Dementia
A Phase 2 study testing BAC in people with Alzheimer's Disease and Vascular Dementia, run by Botanicure Co., Ltd. at 1 site in Taiwan.
Trial 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 more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Alzheimer's Disease, Vascular Dementia
- What is being tested?
- BAC
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteTaiwan
- Study dates
- 30 Jan 2017to 1 Nov 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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
- Alzheimer's Disease, Vascular Dementia
- Being tested
- BAC, BAC Matched Vehicle
- Keywords
- Alzheimer's Disease, Vascular Dementia
- Medical subject headings
- Alzheimer Disease, Dementia, Vascular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BACDrug
Also called CSTC1-BAC
(vapor fraction from seeds of Glycine max (L.) Merr. and composition thereof)
BAC Matched VehicleOther
BAC Matched Vehicle
| Study group | Role | What they receive |
|---|---|---|
| BAC treatment group | Active comparator | BAC, topical application on external nasal skin, scalp, and neck, 30g/day, 2 times daily, for 12 weeks Receives: 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 Receives: Other: BAC Matched Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Weeks 12
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Weeks 4, 8, 12
Net change from baseline in laboratory test results
Items include blood pressures, pulse rate, respiratory rate, and body temperature.
Measured: 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
Measured: Weeks 4, 8, 12]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2015 (estimated)
- Study start30 Jan 2017 (estimated)
- Primary completion1 Nov 2018 (estimated)
- Study completion1 Nov 2018 (estimated)
Why it stopped: The study was withdrawn before participants were enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Botanicure Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- A2 Healthcare Taiwan Corporation
- Responsible party
- Sponsor
- Investigators
- Pai Ming-Chyi, PhD, Principal investigator, Neurology National Cheng Kung University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02467413
- Sponsor's protocol ID
- BAC-01
- Status last verified
- May 2026
- First submitted
- 4 Jun 2015
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02467413
- Acronym / sponsor ID
- BAC-01
- Conditions
- Alzheimer's Disease, Vascular Dementia
- Keywords
- Alzheimer's Disease, Vascular Dementia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was withdrawn before participants were enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Botanicure Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- A2 Healthcare Taiwan Corporation
- Study start
- 30 Jan 2017 (estimated)
- Primary completion
- 1 Nov 2018 (estimated)
- Study completion
- 1 Nov 2018 (estimated)
- First posted
- 10 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BAC treatment group | Active comparator | Drug: BACBAC, topical application on external nasal skin, scalp, and neck, 30g/day, 2 times daily, for 12 weeks |
| BAC Matched vehicle | Placebo comparator | Other: BAC Matched VehicleBAC Matched vehicle, topical application on external nasal skin, scalp, and neck, 30g/day, 2 times daily, for 12 weeks |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BACAlso: CSTC1-BAC(vapor fraction from seeds of Glycine max (L.) Merr. and composition thereof) | Drug | BAC treatment group |
| BAC Matched VehicleBAC Matched Vehicle | Other | BAC Matched vehicle |
Primary outcome
Change in Alzheimer's Disease Assessment Scale- Cognitive (ADAS-cog) score at Week-12 visit compared to baseline
Time frame: Weeks 12
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.
9 secondary outcomes
Change in ADAS-cog score at all post treatment visits (except Week-12 visit) compared to baseline
Time frame: Weeks 4, 8, 12
Clinician's Interview Based Impression of Change-Plus Caregiver Input (CIBIC-plus) score at all post treatment visits
Time frame: Weeks 4, 8, 12
Change in Activities of Daily Living (ADL) score at all post treatment visits compared to baseline
Time frame: Weeks 4, 8, 12
Change in Mini-Mental State Examination (MMSE) score at all post treatment visits compared to baseline
Time frame: Weeks 4, 8, 12
Change in Neuropsychiatric Inventory (NPI) score at all post treatment visits compared to baseline
Time frame: Weeks 4, 8, 12
Adverse event incidence
Time frame: Baseline, Weeks 4, 8, 12
Change in physical examination results
Time frame: Weeks 4, 8, 12
Net change from baseline in laboratory test results
Time frame: Weeks 4, 8, 12
Net change from baseline in vital signs
Time frame: Weeks 4, 8, 12]
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pai Ming-Chyi, PhD principal investigator
Neurology National Cheng Kung University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BAC in people with Alzheimer's Disease and Vascular Dementia, run by Botanicure Co., Ltd. at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Alzheimer's Disease Assessment Scale- Cognitive (ADAS-cog) score at Week-12 visit compared to baseline (time frame: Weeks 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.