Brain Small Chain Fatty Acid Metabolism in Parkinson Disease: Ketones

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-09

Study Completion Date

2023-10-04

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Parkinson Disease Lewy Body Dementia Parkinson Disease Dementia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Parkinson Disease

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.

Group Type EXPERIMENTAL

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

Intervention Type DIETARY_SUPPLEMENT

Ketone ester (KE) dietary supplement (KetoneAid)

Parkinson Disease Dementia/Lewy Body Dementia

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.

Group Type EXPERIMENTAL

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

Intervention Type DIETARY_SUPPLEMENT

Ketone ester (KE) dietary supplement (KetoneAid)

Healthy Controls

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.

Group Type EXPERIMENTAL

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

Intervention Type DIETARY_SUPPLEMENT

Ketone ester (KE) dietary supplement (KetoneAid)

Interventions

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

Ketone ester (KE) dietary supplement (KetoneAid)

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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KetoneAid

Eligibility Criteria

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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

Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes