BAC in Patient With Alzheimer's Disease or Vascular Dementia
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|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Recruitment Status : Withdrawn (The study was withdrawn before participants were enrolled.)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
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer's Disease Vascular Dementia||Drug: BAC Other: BAC Matched Vehicle||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
Active Comparator: BAC treatment group
BAC, topical application on external nasal skin, scalp, and neck, 30g/day, 2 times daily, for 12 weeks
(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
- 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.
- 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.
- 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.
- 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).
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
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
|National Cheng Kung University Hospital|
|Tainan, Taiwan, 704|
|Principal Investigator:||Pai Ming-Chyi, PhD||Neurology National Cheng Kung University Hospital|