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CABA: Creatine to Augment Bioenergetics in Alzheimer's

Sponsor
University of Kansas Medical Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05383833
Collaborator
Alzheimer's Association (Other)
20
Enrollment
1
Location
1
Arm
36
Anticipated Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Creatine Monohydrate
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Creatine to Augment Bioenergetics in Alzheimer's
Anticipated Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Jun 30, 2025
Anticipated Study Completion Date :
Jun 30, 2025

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. Change in Blood Creatine [Baseline, 4 weeks, and 8 weeks]

    Measure of serum creatine levels at baseline, 4 weeks, and 8 weeks.

Secondary Outcome Measures

  1. 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.

  2. 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.

  3. 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.

  4. Change in Muscle Strength [Baseline and 8 weeks]

    Muscle strength will be tested on the right quadriceps femoris (upper leg) using an isokinetic dynamometer.

  5. Change in Muscle Size [Baseline and 8 Weeks]

    Muscle size of the right quadriceps femoris (upper leg) will be determined using ultrasonography (ultrasound).

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years to 90 Years
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Kansas Medical Center Kansas City Kansas United States 66160

Sponsors and Collaborators

  • University of Kansas Medical Center
  • Alzheimer's Association

Investigators

  • Principal Investigator: Matthew Taylor, PhD, RD, University of Kansas Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Matthew Taylor, Assistant Professor, University of Kansas Medical Center
ClinicalTrials.gov Identifier:
NCT05383833
Other Study ID Numbers:
  • 146588
First Posted:
May 20, 2022
Last Update Posted:
May 20, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:
Alzheimer Disease

Study Results

No Results Posted as of May 20, 2022