NCT02886494

A Study to Evaluate Efficacy and Safety of BAC in Patient With Alzheimer's Disease or Vascular Dementia

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Charsire Biotechnology Corp. · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

This study was 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. In each study site, eligible patients were randomized and stratified to 1 of 2 dementia types (Alzheimer's disease and non-Alzheimer's disease) in 3:1 ratio to receive either one of topical application of BAC or BAC matched vehicle, topical application on external nasal skin, scalp, and neck, 2 times daily, 30 g/day. The treatment duration for each patient was 12 weeks, which consisted of 6 visits located at Screening (within 2 weeks before Baseline visit), Baseline (Week 0), Weeks 2, 4, 8, and Week 12 (Final). During the treatment period, patients may continue to receive medications or treatments routinely used for Alzheimer's disease or vascular dementia except those prohibited under this protocol.

Conditions

• Alzheimer's Disease or Vascular Dementia

Interventions

Type	Name	Description
DRUG	BAC treatment	BAC, topical application on external nasal skin, scalp, and neck, 2 times daily, 30 g/day for 12 weeks
DRUG	Matched vehicle	BAC matched vehicle, topical application on external nasal skin, scalp, and neck, 2 times daily, 30 g/day for 12 weeks

Timeline

• Start date: 2016-12-01
• Primary completion: 2018-11-01
• Completion: 2018-11-01
• First posted: 2016-09-01
• Last updated: 2022-10-13
• Results posted: 2021-07-19

Locations

10 sites across 1 country: United States