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Ketone Ester
Brain Small Chain Fatty Acid Metabolism in Parkinson Disease: Ketones
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
No Placebo-Only Group
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
- Dementia
- Parkinson's Disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ after approximately 30 days of intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after approximately 30 days of intervention
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 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
1,860 Previous Clinical Trials
6,437,904 Total Patients Enrolled
9 Trials studying Dementia
1,709 Patients Enrolled for Dementia
Farmer Family FoundationUNKNOWN
Nicolaas Bohnen, MDPrincipal InvestigatorUniversity of Michigan
2 Previous Clinical Trials
26 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are an individual over 45 years old who has been diagnosed with Parkinson Disease.You are 45 years of age or older, and in good health.You take certain medications that affect your nervous system, such as anti-cholinergic, benzodiazepines, high doses of quetiapine, or neuroleptic drugs, on a regular basis.You have a history of severe gastrointestinal (GI) problems.You have serious medical conditions that are not under control.You are pregnant or currently breastfeeding.You are 45 or more years old and have been diagnosed with Parkinson's Disease Dementia or Lewy Body Dementia.You have thoughts about hurting or killing yourself.You drink too much alcohol currently.
Research Study Groups:
This trial has the following groups:- Group 1: Healthy Controls
- Group 2: Parkinson Disease
- Group 3: Parkinson Disease Dementia/Lewy Body Dementia
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.