TerminatedNot Applicable

Brain Small Chain Fatty Acid Metabolism in Parkinson Disease: Ketones

Stopped: Withdrawal of funding

United States16 participantsStarted 2023-03-09

Plain-language summary

Small exploratory open-label pilot study to assess supplementation of a ketone ester (KetoneAid) as a potential therapy for persons with Parkinson disease (PD), Parkinson Disease Dementia/Lewy Body Dementia (PDD/LBD), and healthy controls.

Who can participate

Age range

45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Healthy control volunteers over 45 years of age * People with Parkinson Disease over 45 years of age * People with Parkinson's Disease Dementia or Lewy Body Dementia over 45 years of age Exclusion Criteria: * Participants with contra-indications to MR imaging, including pacemakers or claustrophobia; * Evidence of large vessel stroke or mass lesion on MRI * Regular use of anti-cholinergic, benzodiazepines, high dose (\>100mg QD) of quetiapine, or neuroleptic drugs * History of significant GI disease * Significant metabolic or uncontrolled medical comorbidity * Poorly controlled diabetes * Pregnancy or breast feeding * Current excessive alcohol use * Suicidal ideation

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Glucose Metabolism

Timeframe: Pre and post approximately 30 days of intervention

Clinical Dementia Rating Scale Score

Timeframe: Pre and post approximately 30 days of intervention

Trial details

NCT IDNCT05778695

SponsorUniversity of Michigan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-10-04

Results submitted2024-10-02

View on ClinicalTrials.gov More Parkinson Disease trials

Who can participate

Age range

45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.