Fisetin in Mild Alzheimer's Disease (FIS-AD)

August 19, 2026 updated by: Sunnybrook Health Sciences Centre

Fisetin Intervention Study in Mild Alzheimer's Disease

This pilot study will evaluate the safety and tolerability of the natural health product, fisetin, in older adults with mild cognitive impairment or mild Alzheimer's disease dementia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fisetin
Other: Fisetin
Fisetin 20mg/kg/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Treatment-Emergent Adverse Events (Safety and tolerability of fisetin)
Time Frame: 30 days
Measured using AE reports
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sunnybrook Health Sciences Centre

Collaborators

Sunnybrook Research Institute

Investigators

  • Principal Investigator: Krista Lanctôt, PhD, Sunnybrook Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 27, 2026

Primary Completion (Actual)

July 21, 2026

Study Completion (Actual)

July 21, 2026

Study Registration Dates

First Submitted

November 17, 2025

First Submitted That Met QC Criteria

December 11, 2025

First Posted (Actual)

December 12, 2025

Study Record Updates

Last Update Posted (Actual)

August 20, 2026

Last Update Submitted That Met QC Criteria

August 19, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6705

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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