BAC in Patient With Alzheimer's Disease or Vascular Dementia

Last updated: October 5, 2022
Sponsor: Charsire Biotechnology Corp.
Overall Status: Trial Not Available

Phase

2

Condition

Alzheimer's Disease

Memory Loss

Dementia

Treatment

N/A

Clinical Study ID

NCT02467413
BAC-01
  • Ages > 40
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 theNINDS-AIREN International Workshop criteria or ii. Alzheimer's disease according tothe NIAAA criteria iii. "Mixed" dementia (possible Alzheimer's disease withcerebrovascular disease) according to the NIAAA criteria Note:
  3. NINDS-AIREN: National Institute of Neurological Disorders and Stroke andAssociation Internationale pour la Recherche et l'Enseignement en Neurosciences
  4. NIAAA: National Institute on Aging-Alzheimer's Association
  5. With mild-to-moderate dementia (score of the Mini-Mental State Examination (MMSE)defined as between 10 to 24)
  6. Able to read, write, communicate, and understand cognitive testing instructions
  7. Having a responsible caregiver who spends adequate time daily with the patient; thecaregiver will accompany the patient to all clinic visits during the study andsupervise all study dosing requirements and concomitant medications
  8. Signed, by patients and the responsible caregiver, the written informed consent form

Exclusion

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 vasculardementia (e.g. Parkinson's disease, demyelinated disease of the central nervoussystem, tumor, hydrocephalus, head injury, central nervous system infection includingsyphilis, acquired immune deficiency syndrome, etc.)
  4. With clinical evidence of pulmonary, hepatic, gastrointestinal, metabolic, endocrineor other life threatening diseases judged by investigators not suitable to enter thestudy
  5. With clinically unstable hypertension, diabetes mellitus, and cardiac disease for thelast 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 orplatelet < 100*109/L; creatinine or total bilirubin more than 1.5 times the upperlimit value; alanine aminotransferase (ALT), aspartate aminotransferase (AST),alkaline phosphates (ALP), or γ-glutamyl transferase (γ-GT) more than 2 times theupper limit of normal
  9. With depression, not well-controlled with medications.
  10. With any uncontrolled illness judged by the investigator that entering the trial maybe detrimental to the patient
  11. With known or suspected hypersensitivity to any ingredients of study product andvehicle
  12. Pregnant or lactating or premenopausal with childbearing potential but not takingreliable contraceptive method(s) during the study period
  13. Enrollment in any investigational drug trial within 4 weeks before entering this study

Study Design

Study Start date:
January 30, 2017
Estimated Completion Date:
November 01, 2018

Study 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.

Connect with a study center

  • National Cheng Kung University Hospital

    Tainan, 704
    Taiwan

    Site Not Available

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