Creatine to Augment Bioenergetics in Alzheimer's
- Conditions
- Alzheimer's Disease
- Interventions
- Dietary Supplement: Creatine Monohydrate
- Registration Number
- NCT05383833
- Lead Sponsor
- University of Kansas Medical Center
- Brief Summary
By doing this study, researchers hope to see if creatine monohydrate is a helpful treatment for people with Alzheimer's disease.
- Detailed Description
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:
1. Whether persons with Alzheimer's disease are able to easily take creatine monohydrate for 8 weeks.
2. Whether creatine monohydrate affects thinking function in people with Alzheimer's Disease.
3. Whether creatine monohydrate affects certain biochemicals in the brain and body.
4. Whether creatine monohydrate improves muscle size and strength.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- Diagnosed cognitive impairment due to Alzheimer's disease
- Agreed cooperation from a study partner
- Speaks English as primary language
- Age 60 to 90
- Stable medication for ≥30 days
- BMI ≥ 20.0kg/m2
- Insulin-requiring diabetes, cancer requiring chemotherapy or radiation within the past 5 years, or recent cardiac event (i.e., heart attack, etc.)
- Other neurodegenerative disease
- Ongoing renal disorder or abnormal renal or liver function
- Unable to undergo MRI
- Clinical trial or investigational drug or therapy participation within 30 days of the screening visit
- Non-English speakers
- Inability to perform strength testing
- Weight > 350 lbs.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Creatine Monohydrate Arm Creatine Monohydrate This study a single arm intervention. All participants will receive 20 grams of creatine monohydrate daily for the whole intervention (8 weeks).
- Primary Outcome Measures
Name Time Method Change in Blood Creatine Baseline, 4 weeks, and 8 weeks Measure of serum creatine levels at baseline, 4 weeks, and 8 weeks.
Adherence to Creatine Monohydrate Intervention 8 weeks 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.
- Secondary Outcome Measures
Name Time Method Change in Cognition Baseline and 8 weeks NIH Toolbox (NIH-TB) Cognition Battery will be used to assess changes in a composite global cognition score at baseline and 8 weeks.
Change in Peripheral Mitochondrial Respiration Baseline and 8 weeks Blood platelet and leukocyte mitochondrial respiration (oxygen consumption) will be determined using the Oroboros Oxygraph-2K system.
Change in Brain Creatine Status Baseline and 8 weeks Brain total creatine levels are measured in the brain using magnetic resonance spectroscopy in a 3 T clinical scanner.
Change in Muscle Strength Baseline and 8 weeks Muscle strength will be tested on the right quadriceps femoris (upper leg) using an isokinetic dynamometer.
Change in Muscle Size Baseline and 8 Weeks Muscle size of the right quadriceps femoris (upper leg) will be determined using ultrasonography (ultrasound).
Trial Locations
- Locations (1)
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States