NCT02292238 · Phase 2 · COMPLETED
Benfotiamine in Alzheimer's Disease: A Pilot Study
This trial is testing benfotiamine, a fat-soluble form of vitamin B1, in people with early memory problems or mild Alzheimer's. The idea is that boosting thiamine in the brain may help it use glucose more efficiently and slow cognitive decline. Researchers are measuring thinking scores and brain glucose metabolism with PET scans over one year. This is a Phase 2 pilot study — testing early signals of whether it works and is safe, not a proven therapy.
You may qualify if
- 60 years of age or older
- Clinical diagnosis of AMCI by the Peterson criteria or probable AD dementia according to the National Institute of Neurological Disorders and stroke and the Alzheimer's Disease related Disorders Association (NINCDS/ADRDA)
- MMSE score > or equal to 21
- CDR score > or equal to 0.5 and \< or equal to1
- Cornell Scale for Depression in Dementia(CSDD) score \<10.
- Ambulatory or ambulatory with aide
- Have a caregiver willing to accompany the patient to each visit, accept responsibility for supervising treatment and provided input to clinical outcome assessments
- Reside at home
- Speak English
- Amyloid positive PET-scan
- If they are on AD medications they must be stable on AD medications for at least three months prior to baseline
- Subjects ore willing/able to provide informed consent.
You're excluded if
- Patients with significant neurological disorder other than AD including hypoxia, stroke, traumatic brain injury
- A current psychiatric disorder according the DSM-IV diagnosis of major depression unless successfully treated on a stable dose of an antidepressant for at least 4 weeks and continues on stable dose throughout the study
- Any other DSM-IV Axis l diagnosis including other primary neurodegenerative dementia schizophrenia or bipolar depression
- A current diagnosis of uncontrolled diabetes mellitus (glucose values > 200 mg/ml).
- Patients with uncontrolled diabetes will be excluded because high glucose will alter the FDG-PET studies. The clinic that does PET (Columbia University Medical Center) excludes patients if glucose values exceed 200 mg/ml.
- A current diagnosis of active, uncontrolled seizure disorder
- A current diagnosis of probable or possible vascular dementia according to NINDS-AIREN
- An investigational drug during the previous 4 weeks
- A current diagnosis of severe unstable cardiovascular disease
- A current diagnosis of acute severe, or unstable asthmatic condition (e.g., severe chronic obstructive pulmonary disease (COPD),
- A current diagnosis of cardiac, renal or hepatic disease
- History of alcoholism, current or within past 5 years
- A disability that may prevent the patient from completing all study requirements (e.g., blindness, deafness, severe language difficulty)
- A1C less than or equal to 8
- Current diagnosis of cancer/active treatments
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2022-06-28