An interventional study of Creatine Monohydrate in Alzheimer's Disease, sponsored by University of Kansas Medical Center. Completed at 1 site in United States. Open to participants aged 60 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-08-14.
Sponsored by University of Kansas Medical Center · Not applicable, Interventional, and Treatment
By doing this study, researchers hope to see if creatine monohydrate is a helpful treatment for people with Alzheimer's disease.
Alzheimer's disease is a progressive brain disorder that causes memory and thinking problems. Current medications may temporarily help with symptoms but cannot stop the disease from getting worse. As such, new treatments that slow or stop the disease from progressing are needed.
There is some evidence from animal studies that taking creatine monohydrate may improve thinking in Alzheimer's disease and be good for brain health. However, no studies have looked at creatine monohydrate supplementation in humans with Alzheimer's.
Creatine monohydrate is a dietary supplement regulated by the FDA. This is a study that will test if taking creatine monohydrate may be a helpful treatment for people with Alzheimer's disease. In this study, investigators will will evaluate:
3,765 studies on the registry are indexed under Alzheimer Disease; 881 are open to participants now.
This study's enrollment of 20 is below the median of 68 across 2,861 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →University of Kansas Medical Center is the lead sponsor of 492 studies on the registry; 113 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 24 (63%) have results posted.
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Exclusion Criteria:
This study a single arm intervention. All participants will receive 20 grams of creatine monohydrate daily for the whole intervention (8 weeks).
Dietary Supplement: Creatine Monohydrate
Participants will take 20 grams of creatine monohydrate daily for 8 weeks.The 20 grams will be divided into two equal 10 gram doses that will be stirred into a beverage. One 10 gram dose will be taken in the morning and the other 10 gram dose in evening.
Adherence to Creatine Monohydrate Intervention
Participants will keep a daily supplement tracker (with the help of a consenting study partner). They will also bring unconsumed creatine monohydrate powder to study visits where study personnel will measure and validate against expected intake.
Time frame: 8 weeks
Change in Blood Creatine
Measure of serum creatine levels at baseline, 4 weeks, and 8 weeks.
Time frame: Baseline, 4 weeks, and 8 weeks
Change in Brain Creatine Status
Brain total creatine levels are measured in the brain using magnetic resonance spectroscopy in a 3 T clinical scanner.
Time frame: Baseline and 8 weeks
Change in Cognition
NIH Toolbox (NIH-TB) Cognition Battery will be used to assess changes in a composite global cognition score at baseline and 8 weeks.
Time frame: Baseline and 8 weeks
Change in Peripheral Mitochondrial Respiration
Blood platelet and leukocyte mitochondrial respiration (oxygen consumption) will be determined using the Oroboros Oxygraph-2K system.
Time frame: Baseline and 8 weeks
Change in Muscle Strength
Muscle strength will be tested on the right quadriceps femoris (upper leg) using an isokinetic dynamometer.
Time frame: Baseline and 8 weeks
Change in Muscle Size
Muscle size of the right quadriceps femoris (upper leg) will be determined using ultrasonography (ultrasound).
Time frame: Baseline and 8 Weeks
Plan to share: No
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Creatine monohydrate
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