Alzheimer's Disease
Conditions
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.
Interventions
DIETARY_SUPPLEMENTCreatine 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.
Sponsors
Alzheimer's Association
University of Kansas Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Change in Blood Creatine | Baseline, 4 weeks, and 8 weeks | Measure of serum creatine levels at baseline, 4 weeks, and 8 weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 Size | Baseline and 8 Weeks | Muscle size of the right quadriceps femoris (upper leg) will be determined using ultrasonography (ultrasound). |
| 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 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. |
Countries
United States
Outcome results
None listed