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Ketone Ester

Healthy Controls for Parkinson's Disease

N/A
Waitlist Available
Led By Nicolaas Bohnen, MD
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after approximately 30 days of intervention
Awards & highlights

Summary

This trial is testing a ketone ester supplement to see if it helps people with Parkinson's disease and related conditions by providing an alternative energy source for the brain. The study also includes healthy individuals for comparison. Ketone bodies are alternative energy sources for the brain and have shown potential in protecting neurons in Parkinson's disease models.

Eligible Conditions
  • Parkinson's Disease
  • Dementia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after approximately 30 days of intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and after approximately 30 days of intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Average Glucose metabolism
Clinical Dementia Rating scale score
Fluorodeoxyglucose (FDG) positron emission tomography (PET) brain
Secondary study objectives
Average gait speed
Change in Benton Judgement of Line Orientation scores
Change in scores on the Boston Naming Test
+16 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Parkinson Disease Dementia/Lewy Body DementiaExperimental Treatment1 Intervention
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 II: Parkinson DiseaseExperimental Treatment1 Intervention
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 III: Healthy ControlsExperimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor
1,833 Previous Clinical Trials
6,423,112 Total Patients Enrolled
Farmer Family FoundationUNKNOWN
Nicolaas Bohnen, MDPrincipal InvestigatorUniversity of Michigan
2 Previous Clinical Trials
26 Total Patients Enrolled

Media Library

(R)-3-Hydroxybutyl (R)-3-Hydroxybutyrate (Ketone Ester) Clinical Trial Eligibility Overview. Trial Name: NCT05778695 — N/A
Parkinson's Disease Research Study Groups: Healthy Controls, Parkinson Disease, Parkinson Disease Dementia/Lewy Body Dementia
Parkinson's Disease Clinical Trial 2023: (R)-3-Hydroxybutyl (R)-3-Hydroxybutyrate Highlights & Side Effects. Trial Name: NCT05778695 — N/A
(R)-3-Hydroxybutyl (R)-3-Hydroxybutyrate (Ketone Ester) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05778695 — N/A
~6 spots leftby Sep 2025
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