Creatine to Augment Bioenergetics in Alzheimer's

Study Overview
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Brief Summary
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By doing this study, researchers hope to see if creatine monohydrate is a helpful treatment for people with Alzheimer's disease.

Detailed Description
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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: Whether persons with Alzheimer's disease are able to easily take creatine monohydrate for 8 weeks. Whether creatine monohydrate affects thinking function in people with Alzheimer's Disease. Whether creatine monohydrate affects certain biochemicals in the brain and body. Whether creatine monohydrate improves muscle size and strength.

Official Title
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Creatine to Augment Bioenergetics in Alzheimer's

Conditions
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Alzheimer's Disease

Intervention / Treatment
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* Dietary Supplement: Creatine Monohydrate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Creatine Monohydrate Arm<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 8 weeks | 
| Change in Blood Creatine | Measure of serum creatine levels at baseline, 4 weeks, and 8 weeks. | Baseline, 4 weeks, and 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Brain Creatine Status | Brain total creatine levels are measured in the brain using magnetic resonance spectroscopy in a 3 T clinical scanner. | 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. | 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. | Baseline and 8 weeks | 
| Change in Muscle Strength | Muscle strength will be tested on the right quadriceps femoris (upper leg) using an isokinetic dynamometer. | Baseline and 8 weeks | 
| Change in Muscle Size | Muscle size of the right quadriceps femoris (upper leg) will be determined using ultrasonography (ultrasound). | Baseline and 8 Weeks |