Alzheimer s DiseasePhase 2FIS-ADNCT07279714
Fisetin in Mild Alzheimer's Disease
A Phase 2 study testing Fisetin in people with Alzheimer s Disease and Alzheimer Dementia, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Alzheimer s Disease, Alzheimer Dementia, Alzheimer Dementia (AD)
- What is being tested?
- Fisetin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteCanada
- Study dates
- 27 Jan 2026to 21 Jul 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mild cognitive impairment due to Alzheimer's disease OR mild Alzheimer Dementia
- Moca score of 11 or higher
- Stable psychotropics and cognitive enhancing medications
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Alzheimer s Disease, Alzheimer Dementia, Alzheimer Dementia (AD), Alzheimer Disease, Mild Cognitive Disorder, Neurocognitive Disorders, Mild
- Being tested
- Fisetin
- Keywords
- fisetin, alzheimer's disease, safety, tolerability
- Medical subject headings
- Alzheimer Disease, Neurocognitive Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FisetinOther
Fisetin 20mg/kg/day
| Study group | Role | What they receive |
|---|---|---|
| Fisetin | Experimental | Not described Receives: Other: Fisetin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events (Safety and tolerability of fisetin)
Measured using AE reports
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start27 Jan 2026
- Primary completion21 Jul 2026
- Study completion21 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer s DiseaseStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Sunnybrook Research Institute
- Responsible party
- Sponsor
- Investigators
- Krista Lanctôt, PhD, Principal investigator, Sunnybrook Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07279714
- Sponsor's protocol ID
- 6705
- Acronym
- FIS-AD
- Status last verified
- Dec 2025
- First submitted
- 17 Nov 2025
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fisetin Intervention Study in Mild Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT07279714
- Acronym / sponsor ID
- FIS-AD / 6705
- Conditions
- Alzheimer s Disease, Alzheimer Dementia, Alzheimer Dementia (AD), Alzheimer Disease, Mild Cognitive Disorder, Neurocognitive Disorders, Mild
- Keywords
- fisetin, alzheimer's disease, safety, tolerability
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- Sunnybrook Research Institute
- Study start
- 27 Jan 2026 (actual)
- Primary completion
- 21 Jul 2026 (actual)
- Study completion
- 21 Jul 2026 (actual)
- First posted
- 12 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fisetin | Experimental | Other: Fisetin |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Mild cognitive impairment due to Alzheimer's disease OR mild Alzheimer Dementia
- Moca score of 11 or higher
- Stable psychotropics and cognitive enhancing medications
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FisetinFisetin 20mg/kg/day | Other | Fisetin |
Primary outcome
Incidence of Treatment-Emergent Adverse Events (Safety and tolerability of fisetin)
Time frame: 30 days
Measured using AE reports
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Krista Lanctôt, PhD principal investigator
Sunnybrook Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fisetin in people with Alzheimer s Disease and Alzheimer Dementia, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events (Safety and tolerability of fisetin) (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.