Overview

Brain Small Chain Fatty Acid Metabolism in Parkinson Disease: Ketones

Status:
Not yet recruiting
Trial end date:
2025-05-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
University of Michigan
Collaborator:
Farmer Family Foundation
Criteria
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