Brain Small Chain Fatty Acid Metabolism in Parkinson Disease: Ketones

NCT05778695 | Terminated Results

• 1 other identifier: HUM00213035
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

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.

Conditions

Parkinson Disease; Lewy Body Dementia; Parkinson Disease Dementia

Keywords

ketone ester; ketosis; functional neuroimaging

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Pre and post approximately 30 days of intervention

Study Arms (3)

Parkinson Disease

EXPERIMENTAL

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.

Dietary Supplement: Ketone Ester (R)-3-Hydroxybutyl (R)-3-Hydroxybutyrate

Parkinson Disease Dementia/Lewy Body Dementia

EXPERIMENTAL

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.

Dietary Supplement: Ketone Ester (R)-3-Hydroxybutyl (R)-3-Hydroxybutyrate

Healthy Controls

EXPERIMENTAL

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.

Dietary Supplement: Ketone Ester (R)-3-Hydroxybutyl (R)-3-Hydroxybutyrate

Interventions

Ketone Ester (R)-3-Hydroxybutyl (R)-3-Hydroxybutyrate DIETARY_SUPPLEMENT

Ketone ester (KE) dietary supplement (KetoneAid)

Also known as: KetoneAid

Healthy Controls; Parkinson Disease; Parkinson Disease Dementia/Lewy Body Dementia

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• Farmer Family Foundation: collaborator

Study Sites (2)

Domino's Farms

Ann Arbor, Michigan, 48105, United States

Location

University Hospital

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Lewy Body Disease; Ketosis

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Dementia; Neurocognitive Disorders; Mental Disorders; Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Nicolaas Bohnen, MD, PhD
• Organization: University of Michigan

nbohnen@umich.edu

734-936-1168

Study Officials

• Nicolaas Bohnen, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 21, 2023
• First Posted: March 21, 2023
• Study Start: March 9, 2023
• Primary Completion: October 4, 2023
• Study Completion: October 4, 2023
• Last Updated: February 12, 2025
• Results First Posted: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)