BAC in Patient With Alzheimer's Disease or Vascular Dementia (NCT02467413) | Clinical Trial Compass
WithdrawnPhase 2
BAC in Patient With Alzheimer's Disease or Vascular Dementia
Stopped: The study was withdrawn before participants were enrolled.
Taiwan0Started 2017-01-30
Plain-language 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.
Who can participate
Age range
40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. With either gender aged at least 40 years old
. With a diagnosis of one of the following disease i. Vascular dementia according to the NINDS-AIREN International Workshop criteria or ii. Alzheimer's disease according to the NIAAA criteria iii. "Mixed" dementia (possible Alzheimer's disease with cerebrovascular disease) according to the NIAAA criteria
. NINDS-AIREN: National Institute of Neurological Disorders and Stroke and Association 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial was withdrawn before enrolling anyone — do you know why it was withdrawn, and does that tell us anything important about the safety or effectiveness of the BAC treatment being studied?
2Since this was only a Phase 2 trial, what does that mean about how much we would have known about BAC's safety and benefits even if it had gone ahead — and are there more advanced trials on similar treatments I should look into instead?
3The trial was measuring cognitive changes using the ADAS-cog scale over just 12 weeks — is that a long enough window to tell whether a treatment is really helping someone with Alzheimer's disease or vascular dementia?
4Are there any currently active trials or approved treatments targeting the same goals as this study that might be worth considering instead, given that this one never got off the ground?
5Since this trial accepted both Alzheimer's disease and vascular dementia patients, and those are different conditions, how would you determine which treatment path makes the most sense specifically for my diagnosis?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Alzheimer's Disease Assessment Scale- Cognitive (ADAS-cog) score at Week-12 visit compared to baseline
. Having a responsible caregiver who spends adequate time daily with the patient; the caregiver will accompany the patient to all clinic visits during the study and supervise all study dosing requirements and concomitant medications
. Signed, by patients and the responsible caregiver, the written informed consent form
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 vascular dementia (e.g. Parkinson's disease, demyelinated disease of the central nervous system, tumor, hydrocephalus, head injury, central nervous system infection including syphilis, acquired immune deficiency syndrome, etc.)
. With clinical evidence of pulmonary, hepatic, gastrointestinal, metabolic, endocrine or other life threatening diseases judged by investigators not suitable to enter the study
. With clinically unstable hypertension, diabetes mellitus, and cardiac disease for the last 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 or platelet \< 100\*109/L; creatinine or total bilirubin more than 1.5 times the upper limit value; alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphates (ALP), or γ-glutamyl transferase (γ-GT) more than 2 times the upper limit of normal