Creatine to Augment Bioenergetics in Alzheimer's (CABA)

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

Study Overview

• Status: Recruiting
• Conditions: Alzheimer's Disease
• Intervention / Treatment: Dietary supplement: Creatine Monohydrate

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aaron N Smith, MS, RD; Phone Number: 913-229-5935; Email: asmith71@kumc.edu

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Recruiting
      • University of Kansas Medical Center
      • Contact: Aaron Smith, MS; Phone Number: 913-229-5935; Email: asmith71@kumc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Creatine Monohydrate Arm; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center
• Collaborators: Alzheimer's Association
• Investigators: Principal Investigator: Matthew Taylor, PhD, RD, University of Kansas Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2022
• Primary Completion (Anticipated): June 30, 2025
• Study Completion (Anticipated): June 30, 2025

Study Registration Dates

• First Submitted: April 20, 2022
• First Submitted That Met QC Criteria: May 16, 2022
• First Posted (Actual): May 20, 2022

Study Record Updates

• Last Update Posted (Estimate): January 11, 2023
• Last Update Submitted That Met QC Criteria: January 9, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: 146588

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes