age 55 and older volunteers needed for research study

Baltimore MD

Description

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. 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. All participants will be compensated for their time and research-related inconveniences via NIA debit cards. Participants will be compensated for each Visit as follows: Visit 1 (Screening) $50 Visit 2 $300 Visit 3 $200 Visit 4 $500 Total compensation will be $1050 for participants that complete the study. If you do not complete the study or if the study physician needs to extend your participation due to a missed visit, you will be paid for those visits completed: In case you are unable to complete a Visit, you will be compensated based on the parts that you completed as follows:  blood draws (per session) $25; if two sessions are completed per visit, $50  brain MRI/MRS (per session) $50; if two sessions are completed per visit, $100  optional Thigh MRI (per session) $20; if two sessions are completed per visit, $40  cognitive testing $50,  Stool sample collection $ 10  Urine sample collection $ 10 https://clinicaltrials.gov/ct2/show/NCT04421014 FOR MORE INFORMATION PLEASE CALL: OR Ext. 3941