Brain Small Chain Fatty Acid Metabolism in Parkinson Disease: Ketones

Not Applicable

Terminated

• Conditions: Parkinson Disease; Lewy Body Dementia; Parkinson Disease Dementia
• Interventions: Dietary Supplement: Ketone Ester (R)-3-Hydroxybutyl (R)-3-Hydroxybutyrate

• 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

Arm && Interventions

Group	Intervention	Description
Parkinson Disease	Ketone Ester (R)-3-Hydroxybutyl (R)-3-Hydroxybutyrate	Participants will take the ketone ester supplement for 30 days +/- 7 days. For days 1 through 7, participants will take 12.5g (25mL) of the ketone ester supplement (KetoneAid) TID, and on day 8, the dose will be increased to 25g (50mL) three times daily (TID) as tolerated. KE dose will be titrated down to a tolerated level if necessary.
Healthy Controls	Ketone Ester (R)-3-Hydroxybutyl (R)-3-Hydroxybutyrate	Participants will take the ketone ester supplement for 30 days +/- 7 days. For days 1 through 7, participants will take 12.5g (25mL) of the ketone ester supplement (KetoneAid) TID, and on day 8, the dose will be increased to 25g (50mL) TID as tolerated. KE dose will be titrated down to a tolerated level if necessary.
Parkinson Disease Dementia/Lewy Body Dementia	Ketone Ester (R)-3-Hydroxybutyl (R)-3-Hydroxybutyrate	Participants will take the ketone ester supplement for 30 days +/- 7 days. For days 1 through 7, participants will take 12.5g (25mL) of the ketone ester supplement (KetoneAid) TID, and on day 8, the dose will be increased to 25g (50mL) TID as tolerated. KE dose will be titrated down to a tolerated level if necessary.

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