Clinical Trial: BAC in Patient With Alzheimer's Disease or Vascular Dementia

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

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 Summary:

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.


Sponsor: Charsire Biotechnology Corp.

Current Primary Outcome: Change in Alzheimer's Disease Assessment Scale- Cognitive (ADAS-cog) score at Week-12 visit compared to baseline [ Time Frame: Weeks 12 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Charsire Biotechnology Corp.

Dates:
Date Received: June 4, 2015
Date Started: March 2017
Date Completion: December 2017
Last Updated: February 14, 2017
Last Verified: February 2017