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BAC in Patient With Alzheimer's Disease or Vascular Dementia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02467413
Recruitment Status : Withdrawn (The study was withdrawn before participants were enrolled.)
First Posted : June 10, 2015
Last Update Posted : October 5, 2021
Sponsor:
Collaborator:
A2 Healthcare Taiwan Corporation
Information provided by (Responsible Party):
Charsire Biotechnology Corp.

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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Vascular Dementia Drug: BAC Other: BAC Matched Vehicle Phase 2

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. 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : January 30, 2017
Estimated Primary Completion Date : November 1, 2018
Estimated Study Completion Date : November 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
(vapor fraction from seeds of Glycine max (L.) Merr. and composition thereof)
Other Name: CSTC1-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
BAC Matched Vehicle




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Change in ADAS-cog score at all post treatment visits (except Week-12 visit) compared to baseline [ Time Frame: Weeks 4, 8, 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.

  2. Clinician's Interview Based Impression of Change-Plus Caregiver Input (CIBIC-plus) score at all post treatment visits [ Time Frame: Weeks 4, 8, 12 ]
    This is a global measure of detectable change in cognition, function and behavior.

  3. Change in Activities of Daily Living (ADL) score at all post treatment visits compared to baseline [ Time Frame: Weeks 4, 8, 12 ]
    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).

  4. Change in Mini-Mental State Examination (MMSE) score at all post treatment visits compared to baseline [ Time Frame: Weeks 4, 8, 12 ]
    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.

  5. Change in Neuropsychiatric Inventory (NPI) score at all post treatment visits compared to baseline [ Time Frame: Weeks 4, 8, 12 ]
    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.

  6. Adverse event incidence [ Time Frame: Baseline, Weeks 4, 8, 12 ]
    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.

  7. Change in physical examination results [ Time Frame: Weeks 4, 8, 12 ]
    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.

  8. Net change from baseline in laboratory test results [ Time Frame: Weeks 4, 8, 12 ]
    Items include blood pressures, pulse rate, respiratory rate, and body temperature.

  9. Net change from baseline in vital signs [ Time Frame: Weeks 4, 8, 12] ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02467413


Locations
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Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan, 704
Sponsors and Collaborators
Charsire Biotechnology Corp.
A2 Healthcare Taiwan Corporation
Investigators
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Principal Investigator: Pai Ming-Chyi, PhD Neurology National Cheng Kung University Hospital
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Responsible Party: Charsire Biotechnology Corp.
ClinicalTrials.gov Identifier: NCT02467413    
Other Study ID Numbers: BAC-01
First Posted: June 10, 2015    Key Record Dates
Last Update Posted: October 5, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Charsire Biotechnology Corp.:
Alzheimer's Disease
Vascular Dementia
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Dementia, Vascular
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cerebrovascular Disorders
Intracranial Arteriosclerosis
Intracranial Arterial Diseases
Leukoencephalopathies
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases