Clinical trial NCT05383833: Creatine to Augment Bioenergetics in Alzheimer's
Official title: Creatine to Augment Bioenergetics in Alzheimer's
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer's Disease
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: Alzheimer's Association
First posted: 2022-05-20
Enrollment: 20
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Adherence to Creatine Monohydrate Intervention
timeFrame: 8 weeks
measure: Change in Blood Creatine
timeFrame: Baseline, 4 weeks, and 8 weeks
Secondary outcomes:
measure: Change in Brain Creatine Status
timeFrame: Baseline and 8 weeks
measure: Change in Cognition
timeFrame: Baseline and 8 weeks
measure: Change in Peripheral Mitochondrial Respiration
timeFrame: Baseline and 8 weeks
measure: Change in Muscle Strength
timeFrame: Baseline and 8 weeks
measure: Change in Muscle Size
timeFrame: Baseline and 8 Weeks
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Matthew Taylor, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References: