Heat Therapy for Alzheimer's Prevention

(FIGHT-AD Trial)

Overseen By Jill Morris, PhD

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: University of Kansas Medical Center

Must not be taking: Psychoactive, Investigational

Disqualifiers: Type 1 diabetes, Cancer, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 10 weeks

60 Participants Needed

Trial Summary

What is the purpose of this trial?

The investigators will determine if heat therapy can improve blood (Aim 1) and brain (Aim 2) glucose metabolism in cognitively healthy older adults (65+) who are at risk for AD. The investigators will also examine the degree to which changes in blood and brain glucose metabolism track together and explore several additional potential mechanisms that are critical to understanding the brain benefits of heat therapy (Aim 3). These aims will provide a comprehensive understanding of the impact of heat therapy on whole body metabolic function and brain health.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it requires that your medication doses have been stable for more than one month before joining.

How does heat therapy differ from other treatments for Alzheimer's prevention?

Heat therapy for Alzheimer's prevention is unique because it focuses on using heat to potentially improve blood flow and promote the clearance of harmful proteins in the brain, unlike other treatments that often involve medications or lifestyle changes like diet and exercise. This approach is novel as it targets the vascular system to aid in the removal of amyloid-beta, a protein linked to Alzheimer's, which is not a common focus in existing treatments. ^{1 2 3 4 5}

Research Team

Jill Morris, PhD

Principal Investigator

University of Kansas Medical Center

Eligibility Criteria

This trial is for people aged 65 or older who are cognitively healthy but at risk for Alzheimer's Disease. They should have stable medication doses, be post-menopausal, and may have a history of metabolic issues like pre-diabetes. Those with Type 1 Diabetes, high cardiovascular risk without clearance, certain chronic diseases, heat intolerance conditions or recent heart problems cannot join.

Inclusion Criteria

I have a history of or currently have a metabolic condition like pre-diabetes or Type 2 Diabetes.

I have gone through menopause.

I am 65 years old or older.

Exclusion Criteria

I have not had a heart attack or heart disease symptoms in the last 2 years.

I do not have severe depression, use psychoactive drugs, or have major hearing or vision problems.

I cannot have an MRI or have a pacemaker that needs clearance.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo 10 weeks of heat therapy to improve blood and brain glucose metabolism

10 weeks

3 visits per week (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Water Immersion Heat Therapy

Trial Overview The study tests if water immersion heat therapy can improve blood and brain glucose metabolism in older adults to prevent Alzheimer's Disease. It will also explore how these changes might benefit overall brain health and body metabolism.

Participant Groups

Group I: Heat therapy Group Experimental Treatment 1 Intervention

40.5°C water

Group II: Thermoneutral Control Group Placebo Group 1 Intervention

36°C water

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials

527

Recruited

181,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Development of a Multicomponent Intervention to Prevent Alzheimer's Disease. [2020]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Beneficial Effects of an Integrated Psychostimulation Program in Patients with Alzheimer's Disease. [2018]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Novel Nutraceutical Compounds in Alzheimer Prevention. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Therapies for Prevention and Treatment of Alzheimer's Disease. [2022]

5. France pubmed.ncbi.nlm.nih.gov

Recruitment methods for United States Alzheimer disease prevention trials. [2021]