Ketone Ester Effects on Biomarkers of Brain Metabolism and Cognitive Performance in Cognitively I… (NCT04421014) | Clinical Trial Compass
CompletedNot Applicable
Ketone Ester Effects on Biomarkers of Brain Metabolism and Cognitive Performance in Cognitively Intact Adults 55 Years Old or Older
United States99 participantsStarted 2021-06-24
Plain-language summary
Background:
In Alzheimer s disease (AD) the brain cannot use glucose as a fuel. The brain can use ketones as a fuel instead of glucose. Researchers want to test a supplement, Ketone Ester (KE). It may improve brain metabolic function and cognition in normal people and, perhaps, down the road, in patients with AD.
Objective:
To study the change in brain ketone levels in people after 28 days of taking KE compared with baseline and placebo. Also, to study changes in cognitive performance.
Eligibility:
People 55 years old or older with metabolic syndrome and no cognitive impairment
Design:
Participants will have 4 visits.
Participants will be screened at Visit 1 with:
Medical history
Physical exam
Blood and urine tests
Cognitive testing
Participants will be randomly assigned to receive either the study supplement or a placebo with same amount of calories. Neither they nor the researchers will know which they receive.
Visit 2 will include repeats of some screening tests. It will also include:
Stool sample (brought from home)
MRI/MRS: Participants will lie on a table that slides in and out of a scanner. A coil will be placed over their head. They may be asked to perform leg exercises.
First dose of study supplement or placebo
About 2 weeks after Visit 2, Visit 3 will include blood and urine tests and a questionnaire.
About 2 weeks after Visit 3, Visit 4 will include repeats of the Visit 2 tests.
Participants will drink the study supplement or placebo 3 times per day during the study. They will keep a daily log of each dose. They will bring the log to Visits 3 and 4.
Participants will by contacted by phone once per week during the study to see how they are doing.
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Who can participate
Age range55 Years
SexALL
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Inclusion criteria
✓. Ability to provide informed consent and willingness to sign a written informed consent document
✓. Male or female, age \>=55 years old
✓. Cognitively intact status ascertained during screening (defined as absence of significant memory or cognitive changes in the last 2 years by subjective report, Clinical Dementia Rating (CDR) of 0, and Montreal Cognitive Assessment (MoCA) \>= 26)
✓. Ability to take oral medications
✓. Willingness to adhere to all study procedures including having MRI/MRS.
✓. Presence of Metabolic Syndrome (MetS). Specifically, they should meet three of the five following MetS diagnostic criteria to be eligible:
Exclusion criteria
✕. Previously diagnosed with a condition causing clinically significant cognitive impairment, such as MCI, AD or other type of dementia (such as vascular dementia, Lewy body dementia and frontotemporal dementia).
✕. History of clinically significant brain disorders, such as stroke, multiple sclerosis, Parkinson s disease or other movement disorders, brain tumors, history of meningitis or encephalitis, history of moderate or severe traumatic brain injury (defined as Glasgow Coma Scale of 12 or less), epilepsy. Certain common neurological disorders not considered relevant (e.g. migraine, essential tremor) or incidental neuroimaging findings that are common and of uncertain clinical significance (e.g. mild-moderate microvascular changes on MRI) may be allowed.
What they're measuring
1
Change in β-hydroxybutyrate in the Posteromedial Cortex Measured by ¹H-MRS (PRESS)
Timeframe: Week 0 and Week 4 (pre-drink and ~75 minutes post-drink)
✕. Chronic and significant psychiatric conditions (e.g. history of bipolar disorder, schizophrenia, PTSD, moderate to severe depression or treatment-resistant depression. Unipolar depression or anxiety disorder may be allowed if mild or if successfully treated with single anti-depressant or anti-anxiety agents.
✕. Positive urine drug screen (and no prescription medication accounting for the positive test).
✕. Positive HIV, HBV or HCV status during screening.
✕. Contraindications for MRI (pregnancy, pacemakers or other implanted devices, ferrous metal implants or shrapnel in or around the head etc.).
✕. Anemia (defined as HGB \< 12 for men or \< 11 g/dl for women)