Brain Small Chain Fatty Acid Metabolism in Parkinson Disease: Ketones

University of Michigan

Status: Terminated

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

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05778695

HUM00213035

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 45+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 3 patient groups

Parkinson Disease

Experimental group

Description:

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.

Treatment:

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

Parkinson Disease Dementia/Lewy Body Dementia

Experimental group

Description:

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.

Treatment:

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

Healthy Controls

Experimental group

Description:

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.

Treatment:

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