Brain Small Chain Fatty Acid Metabolism in Parkinson Disease: Ketones

Not Applicable

Terminated

• Conditions: Parkinson Disease; Lewy Body Dementia; Parkinson Disease Dementia

• Registration Number: NCT05778695
• Lead Sponsor: University of Michigan

Brief 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.

Detailed Description

The overarching goal of this study is to investigate glucose metabolic, cognitive, clinical and imaging changes in persons with PD and PDD/LBD before and after a month supplementation of a ketone ester (KetoneAid) in a small open label exploratory clinical trial. Positive findings in this small exploratory pilot trial may support future target engagement studies of ketone supplementation in PD and normal adults.

Study Timeline

• Study First Submitted: 2023-02-21
• Study Start: 2023-03-09
• Study First Submitted QC: 2023-03-09
• Study First Posted: 2023-03-21
• Primary Completion: 2023-10-04
• Study Completion: 2023-10-04
• Results First Submitted: 2024-10-02
• Status Verified: 2025-02
• Results First Submitted QC: 2025-02-10
• Last Update Submitted: 2025-02-10
• Results First Posted: 2025-02-12
• Last Update Posted: 2025-02-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Glucose Metabolism	Pre and post approximately 30 days of intervention	Continuous glucose meter 7-10-day average glucose readings before/after open-label treatment with the ketone ester in patients with PD, Parkinson's disease dementia/Lewy body dementia, and normal controls. Healthy fasting blood glucose ranges from 70 to 99 milligrams per deciliter (mg/dL), with a healthy maximum of 180 mg/dL within 2 hours of eating meals.
Clinical Dementia Rating Scale Score	Pre and post approximately 30 days of intervention	The clinical dementia rating scale is a measure of functional and cognitive performance relevant to dementia. It is scored from 0 (normal) to 3 (severe dementia). The clinical dementia rating scale will be assessed in patients with Parkinson's disease, Parkinson's disease dementia/Lewy body dementia, and healthy controls before and after open-label treatment with the ketone ester.

Trial Locations

Locations (2)

Domino's Farms; 🇺🇸 Ann Arbor, Michigan, United States

University Hospital; 🇺🇸 Ann Arbor, Michigan, United States