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BAC in Patient With Alzheimer's Disease or Vascular Dementia

Primary Purpose

Alzheimer's Disease, Vascular Dementia

Status

Withdrawn

Phase

Phase 2

Locations

Taiwan

Study Type

Interventional

Intervention

BAC

BAC Matched Vehicle

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring Alzheimer's Disease, Vascular Dementia

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

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

Sites / Locations

National Cheng Kung University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

BAC treatment group

BAC Matched vehicle

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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).

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.

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.

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.

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.

Net change from baseline in laboratory test results

Items include blood pressures, pulse rate, respiratory rate, and body temperature.

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

Full Information

NCT ID

NCT02467413

First Posted

June 4, 2015

Last Updated

October 5, 2022

Sponsor

Charsire Biotechnology Corp.

Collaborators

A2 Healthcare Taiwan Corporation

1. Study Identification

Unique Protocol Identification Number

NCT02467413

Brief Title

BAC in Patient With Alzheimer's Disease or Vascular Dementia

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Withdrawn

Why Stopped

The study was withdrawn before participants were enrolled.

Study Start Date

January 30, 2017 (Anticipated)

Primary Completion Date

November 1, 2018 (Anticipated)

Study Completion Date

November 1, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Charsire Biotechnology Corp.

Collaborators

A2 Healthcare Taiwan Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer's Disease, Vascular Dementia

Keywords

Alzheimer's Disease, Vascular Dementia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BAC treatment group

Arm Type

Active Comparator

Arm Description

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

Arm Title

BAC Matched vehicle

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

BAC

Other Intervention Name(s)

CSTC1-BAC

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

BAC Matched Vehicle

Intervention Description

BAC Matched Vehicle

Primary Outcome Measure Information:

Title

Change in Alzheimer's Disease Assessment Scale- Cognitive (ADAS-cog) score at Week-12 visit compared to baseline

Description

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 Outcome Measure Information:

Title

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

Description

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

Title

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

Description

This is a global measure of detectable change in cognition, function and behavior.

Time Frame

Weeks 4, 8, 12

Title

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

Description

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

Title

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

Description

Time Frame

Weeks 4, 8, 12

Title

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

Description

Time Frame

Weeks 4, 8, 12

Title

Adverse event incidence

Description

Time Frame

Baseline, Weeks 4, 8, 12

Title

Change in physical examination results

Description

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

Title

Net change from baseline in laboratory test results

Description

Items include blood pressures, pulse rate, respiratory rate, and body temperature.

Time Frame

Weeks 4, 8, 12

Title

Net change from baseline in vital signs

Description

Time Frame

Weeks 4, 8, 12]

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: 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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pai Ming-Chyi, PhD

Organizational Affiliation

Neurology National Cheng Kung University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Cheng Kung University Hospital

City

Tainan

ZIP/Postal Code

704

Country

Taiwan

12. IPD Sharing Statement

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BAC in Patient With Alzheimer's Disease or Vascular Dementia

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