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Recruiting

NCT Number: NCT07279714

Fisetin 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.

Recruiting

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sunnybrook Research Institute

Toronto, Ontario, M4N 3M5, Canada

Location status: Recruiting

Location contact

Krista Lanctôt, PhD

PRINCIPAL_INVESTIGATOR

Study Coordinator

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fisetin

Other

Fisetin 20mg/kg/day

Primary outcomes

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

    Time frame: 30 days

    Measured using AE reports

Study contacts

Contact information is provided by the study sponsor or research team.

Study Coordinator

CONTACT

[email protected]

416-480-6100 ext. 63185

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Collaborators

  • Sunnybrook Research Institute

Registry information

Official study title

Fisetin Intervention Study in Mild Alzheimer's Disease

Acronym: FIS-AD

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Dec 12, 2025
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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