BAC in Patient With Alzheimer's Disease or Vascular Dementia

Alzheimer's Disease Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02467413
• Other study ID #: BAC-01
• Status: Withdrawn
• Phase: Phase 2
• Start date: January 30, 2017
• Est. completion date: November 1, 2018

Study information

• Verified date: October 2022
• Source: Charsire Biotechnology Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 1, 2018
• Est. primary completion date: November 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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 ?-glutamyl transferase (?-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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Dementia
• Dementia, Vascular
• Vascular Dementia

Intervention

Drug:
• BAC
(vapor fraction from seeds of Glycine max (L.) Merr. and composition thereof)

Other:
• BAC Matched Vehicle
BAC Matched Vehicle

Locations

Country	Name	City	State
Taiwan	National Cheng Kung University Hospital	Tainan

Sponsors (2)

Lead Sponsor	Collaborator
Charsire Biotechnology Corp.	A2 Healthcare Taiwan Corporation

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Weeks 4, 8, 12
Secondary	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.	Weeks 4, 8, 12
Secondary	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).	Weeks 4, 8, 12
Secondary	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.	Weeks 4, 8, 12
Secondary	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.	Weeks 4, 8, 12
Secondary	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.	Baseline, Weeks 4, 8, 12
Secondary	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.	Weeks 4, 8, 12
Secondary	Net change from baseline in laboratory test results	Items include blood pressures, pulse rate, respiratory rate, and body temperature.	Weeks 4, 8, 12
Secondary	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), ?-glutamyl transferase (?-GT), serum creatinine, blood urea nitrogen (BUN), albumin, total protein, alkaline phosphatase, total bilirubin	Weeks 4, 8, 12]