Creatine to Augment Bioenergetics in Alzheimer's

Alzheimer's Disease Clinical Trial

— CABA  

Official title:

Creatine to Augment Bioenergetics in Alzheimer's

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05383833
• Other study ID #: 146588
• Status: Recruiting
• Phase: N/A
• Start date: December 12, 2022
• Est. completion date: June 30, 2025

Study information

• Verified date: January 2023
• Source: University of Kansas Medical Center
• Contact: Aaron N Smith, MS, RD
• Phone: 913-229-5935
• Email: asmith71[@]kumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Dietary Supplement:
• Creatine 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.

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Kansas Medical Center	Alzheimer's Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change in Blood Creatine	Measure of serum creatine levels at baseline, 4 weeks, and 8 weeks.	Baseline, 4 weeks, and 8 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in Muscle Strength	Muscle strength will be tested on the right quadriceps femoris (upper leg) using an isokinetic dynamometer.	Baseline and 8 weeks
Secondary	Change in Muscle Size	Muscle size of the right quadriceps femoris (upper leg) will be determined using ultrasonography (ultrasound).	Baseline and 8 Weeks