NCT07279714

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_2

Timeline
6mo left

Started Jan 2026

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress36%
Jan 2026Nov 2026

First Submitted

Initial submission to the registry

November 17, 2025

Completed
25 days until next milestone

First Posted

Study publicly available on registry

December 12, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

January 27, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

April 13, 2026

Status Verified

December 1, 2025

Enrollment Period

9 months

First QC Date

November 17, 2025

Last Update Submit

April 10, 2026

Conditions

Keywords

fisetinalzheimer's diseasesafetytolerability

Outcome Measures

Primary Outcomes (1)

  • Incidence of Treatment-Emergent Adverse Events (Safety and tolerability of fisetin)

    Measured using AE reports

    30 days

Study Arms (1)

Fisetin

EXPERIMENTAL
Other: Fisetin

Interventions

FisetinOTHER

Fisetin 20mg/kg/day

Fisetin

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Mild cognitive impairment due to Alzheimer's disease OR mild Alzheimer Dementia
  • Moca score of 11 or higher
  • Stable psychotropics and cognitive enhancing medications

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sunnybrook Research Institute

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

MeSH Terms

Conditions

Alzheimer DiseaseNeurocognitive Disorders

Interventions

fisetin

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesMental Disorders

Study Officials

  • Krista Lanctôt, PhD

    Sunnybrook Research Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2025

First Posted

December 12, 2025

Study Start

January 27, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

April 13, 2026

Record last verified: 2025-12

Locations