NCT02467413

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• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Charsire Biotechnology Corp. · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Alzheimer's Disease
• Vascular Dementia

Interventions

Type	Name	Description
DRUG	BAC	(vapor fraction from seeds of Glycine max (L.) Merr. and composition thereof)
OTHER	BAC Matched Vehicle	BAC Matched Vehicle

Timeline

• Start date: 2017-01-30
• Primary completion: 2018-11-01
• Completion: 2018-11-01
• First posted: 2015-06-10
• Last updated: 2022-10-07

Locations

1 site across 1 country: Taiwan

Regulatory

• FDA-regulated drug study