Fisetin for mild Alzheimer's disease
Fisetin Intervention Study in Mild Alzheimer's Disease
This pilot will test whether the natural supplement fisetin is safe and tolerable for older adults with mild cognitive impairment or mild Alzheimer's dementia.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 5 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | Sunnybrook Health Sciences Centre Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT07279714 on ClinicalTrials.gov |
What this trial studies
This Phase 2 pilot interventional study gives oral fisetin to older adults with mild cognitive impairment or mild Alzheimer's dementia and monitors them for safety and tolerability. Eligible participants must have a MoCA score of 11 or higher and be on stable psychotropic or cognitive-enhancing medications. Investigators will track adverse events, routine blood tests, and cognitive screening during scheduled clinic visits to detect any safety signals and measure tolerability. The single-site trial at Sunnybrook Research Institute excludes people with unstable medical conditions, active infections or cancer treatment, recent bleeding, substance use disorders, certain interacting medications, or recent use of other senolytic/antioxidant supplements.
Who should consider this trial
Good fit: Ideal candidates are older adults with mild cognitive impairment due to Alzheimer's or mild Alzheimer's dementia, a MoCA score of 11 or higher, and stable psychotropic or cognitive-enhancing medications who can attend visits at Sunnybrook in Toronto.
Not a fit: People with moderate to advanced Alzheimer's, other neurologic causes of cognitive impairment, unstable medical conditions, ongoing cancer treatment, active infections, active substance or alcohol use disorder, recent bleeding, or who take oral anticoagulants, anti-cancer, anti-seizure drugs, or interacting supplements are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the trial could show fisetin is safe and tolerable in people with early Alzheimer's changes and support larger trials to test whether it helps cognition or disease progression.
How similar studies have performed: Preclinical data and very limited early human work suggest senolytics like fisetin may have biological effects, but clinical evidence in Alzheimer's is sparse and this approach remains largely unproven in humans.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Mild cognitive impairment due to Alzheimer's disease OR mild Alzheimer Dementia * Moca score of 11 or higher * Stable psychotropics and cognitive enhancing medications Exclusion Criteria: * Known hypersensitivity or allergy to fisetin * Presence of any medical condition, or abnormal routine blood test, that the investigator believes would put the subject at risk or would preclude the patient from completing all aspects of the trial * Unstable medical disorders * Ongoing treatment for active infection with antibiotics/antifungals * Ongoing treatment for cancer * Active alcohol or substance use disorder * Recent active bleeding * Patients taking oral anticoagulants, anti-cancer, anti-seizure medications, or other medications that could have a significant interaction with fisetin * Use within the last month of other senolytic supplements, antioxidant supplements, natural health products * Other neurologic or neurodegenerative conditions impacting cognition * Active Major Depressive Episode, active suicidal thoughts or psychosis * Any thing that would preclude the ability to undergo an MRI scan
Where this trial is running
Toronto, Ontario
- Sunnybrook Research Institute — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Krista Lanctôt, PhD — Sunnybrook Research Institute
- Study coordinator: Study Coordinator
- Email: memoryresearch@sunnybrook.ca
- Phone: 416-480-6100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.