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Completed

NCT Number: NCT05383833

Creatine to Augment Bioenergetics in Alzheimer's

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

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Key information

Age range

60 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

About this study

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:

  • Whether persons with Alzheimer's disease are able to easily take creatine monohydrate for 8 weeks.
  • Whether creatine monohydrate affects thinking function in people with Alzheimer's Disease.
  • Whether creatine monohydrate affects certain biochemicals in the brain and body.
  • Whether creatine monohydrate improves muscle size and strength.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Creatine Monohydrate

Dietary Supplement

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.

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Collaborators

  • Alzheimer's Association

Registry information

Acronym: CABA

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
May 20, 2022
Registry last updated
Aug 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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