Creatine to Augment Bioenergetics in Alzheimer's (CABA)

University of Kansas

Status: Completed

Conditions: Alzheimer's Disease

Treatments: Dietary Supplement: Creatine Monohydrate

Study type: Interventional

Funder types: Other

Identifiers

NCT05383833

148507

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 60 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Creatine Monohydrate Arm

Experimental group

Description:

This study a single arm intervention. All participants will receive 20 grams of creatine monohydrate daily for the whole intervention (8 weeks).

Treatment:

Dietary Supplement: Creatine Monohydrate