Brain Small Chain Fatty Acid Metabolism in Parkinson Disease: Ketones

University of Michigan16 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Parkinson Disease Lewy Body Dementia Parkinson Disease Dementia

Interventions

Ketone Ester (R)-3-Hydroxybutyl (R)-3-HydroxybutyrateDIETARY_SUPPLEMENT

Ketone ester (KE) dietary supplement (KetoneAid)

Eligibility

Sex: ALLMin age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Domino's Farms

Ann Arbor, Michigan, United States

University Hospital

Ann Arbor, Michigan, United States

Outcomes

Primary Outcomes

Glucose Metabolism

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.

Time frame: Pre and post approximately 30 days of intervention

Clinical Dementia Rating Scale Score

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.

Time frame: Pre and post approximately 30 days of intervention

Data from ClinicalTrials.gov

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