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/AClinical Study ID
NCT02467413
BAC-01
Ages > 40 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria: A patient is eligible for the study if all of the following apply:
- With either gender aged at least 40 years old
- 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:
- NINDS-AIREN: National Institute of Neurological Disorders and Stroke andAssociation Internationale pour la Recherche et l'Enseignement en Neurosciences
- NIAAA: National Institute on Aging-Alzheimer's Association
- With mild-to-moderate dementia (score of the Mini-Mental State Examination (MMSE)defined as between 10 to 24)
- Able to read, write, communicate, and understand cognitive testing instructions
- 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
- Signed, by patients and the responsible caregiver, the written informed consent form
Exclusion
Exclusion Criteria:
- With large-artery stroke (thrombotic stroke)
- With radiological evidence of other brain disorders (subdural hematoma, post-traumatic / post-surgery)
- 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.)
- With clinical evidence of pulmonary, hepatic, gastrointestinal, metabolic, endocrineor other life threatening diseases judged by investigators not suitable to enter thestudy
- With clinically unstable hypertension, diabetes mellitus, and cardiac disease for thelast 3 months
- With history of stroke and hospitalized for stroke in the previous 3 months
- With history of alcohol or drug abuse
- 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
- With depression, not well-controlled with medications.
- With any uncontrolled illness judged by the investigator that entering the trial maybe detrimental to the patient
- With known or suspected hypersensitivity to any ingredients of study product andvehicle
- Pregnant or lactating or premenopausal with childbearing potential but not takingreliable contraceptive method(s) during the study period
- 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
Connect with a study center
National Cheng Kung University Hospital
Tainan, 704
TaiwanSite Not Available

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