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Creatine to Augment Bioenergetics in Alzheimer's (CABA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05383833
Recruitment Status : Recruiting
First Posted : May 20, 2022
Last Update Posted : January 11, 2023
Sponsor:
Collaborator:
Alzheimer's Association
Information provided by (Responsible Party):
Matthew Taylor, University of Kansas Medical Center

Study Description
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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
Alzheimer's Disease Dietary Supplement: Creatine Monohydrate Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated 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
Actual Study Start Date : December 12, 2022
Estimated Primary Completion Date : June 30, 2025
Estimated Study Completion Date : June 30, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. Adherence to Creatine Monohydrate Intervention [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Baseline and 8 Weeks ]
    Muscle size of the right quadriceps femoris (upper leg) will be determined using ultrasonography (ultrasound).


Eligibility Criteria
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Ages Eligible for Study:   60 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05383833


Contacts
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Contact: Aaron N Smith, MS, RD 913-229-5935 asmith71@kumc.edu

Locations
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United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Contact: Aaron Smith, MS    913-229-5935    asmith71@kumc.edu   
Sponsors and Collaborators
University of Kansas Medical Center
Alzheimer's Association
Investigators
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Principal Investigator: Matthew Taylor, PhD, RD University of Kansas Medical Center
More Information
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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    Key Record Dates
Last Update Posted: January 11, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders