Alzheimer's DiseaseCABANCT05383833
Creatine to Augment Bioenergetics in Alzheimer's
A study testing Creatine Monohydrate in people with Alzheimer's Disease, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
By doing this study, researchers hope to see if creatine monohydrate is a helpful treatment for people with Alzheimer's disease. Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Creatine Monohydrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2022to 14 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
By doing this study, researchers hope to see if creatine monohydrate is a helpful treatment for people with Alzheimer's disease.
Read the 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:
- 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.
- Conditions
- Alzheimer's Disease
- Being tested
- Creatine Monohydrate
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Creatine MonohydrateDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Creatine Monohydrate Arm | Experimental | This study a single arm intervention. All participants will receive 20 grams of creatine monohydrate daily for the whole intervention (8 weeks). Receives: Dietary Supplement: Creatine Monohydrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Change in Blood Creatine
Measure of serum creatine levels at baseline, 4 weeks, and 8 weeks.
Measured: Baseline, 4 weeks, and 8 weeks
Secondary outcomes (5)
Change in Brain Creatine Status
Brain total creatine levels are measured in the brain using magnetic resonance spectroscopy in a 3 T clinical scanner.
Measured: 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.
Measured: 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.
Measured: Baseline and 8 weeks
Change in Muscle Strength
Muscle strength will be tested on the right quadriceps femoris (upper leg) using an isokinetic dynamometer.
Measured: Baseline and 8 weeks
Change in Muscle Size
Muscle size of the right quadriceps femoris (upper leg) will be determined using ultrasonography (ultrasound).
Measured: Baseline and 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2022
- Study start12 Dec 2022
- Primary completion14 May 2024
- Study completion14 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Alzheimer's Association
- Responsible party
- Principal investigator, Matthew Taylor, University of Kansas Medical Center
- Investigators
- Matthew Taylor, PhD, RD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05383833
- Sponsor's protocol ID
- 148507
- Acronym
- CABA
- Status last verified
- Aug 2024
- First submitted
- 20 Apr 2022
- Last updated
- 14 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
K Taylor M, Smith AN, Choi IY, Lee P, Kelly E, Arora T, Sullivan DK, Burns JM, Swerdlow RH, Wilkins HM. Bioenergetic data from a creatine monohydrate pilot trial in Alzheimer's disease. Alzheimers Dement (N Y). 2026 Feb 22;12(1):e70228. doi: 10.1002/trc2.70228. eCollection 2026 Jan-Mar.
PubMed 41737290Smith AN, Sullivan DK, Morris JK, Carbuhn AF, Herda TJ, Taylor MK. Eight weeks of creatine monohydrate supplementation is associated with increased muscle strength and size in Alzheimer's disease: data from a single-arm pilot study. Front Nutr. 2025 Sep 4;12:1670641. doi: 10.3389/fnut.2025.1670641. eCollection 2025.
PubMed 40977987Smith AN, Choi IY, Lee P, Sullivan DK, Burns JM, Swerdlow RH, Kelly E, Taylor MK. Creatine monohydrate pilot in Alzheimer's: Feasibility, brain creatine, and cognition. Alzheimers Dement (N Y). 2025 May 19;11(2):e70101. doi: 10.1002/trc2.70101. eCollection 2025 Apr-Jun.
PubMed 40395689Taylor MK, Burns JM, Choi IY, Herda TJ, Lee P, Smith AN, Sullivan DK, Swerdlow RH, Wilkins HM. Protocol for a single-arm, pilot trial of creatine monohydrate supplementation in patients with Alzheimer's disease. Pilot Feasibility Stud. 2024 Feb 27;10(1):42. doi: 10.1186/s40814-024-01469-5.
PubMed 38414003
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creatine to Augment Bioenergetics in Alzheimer's
- ClinicalTrials.gov ID
- NCT05383833
- Acronym / sponsor ID
- CABA / 148507
- Conditions
- Alzheimer's Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- Alzheimer's Association
- Study start
- 12 Dec 2022 (actual)
- Primary completion
- 14 May 2024 (actual)
- Study completion
- 14 May 2024 (actual)
- First posted
- 20 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
By doing this study, researchers hope to see if creatine monohydrate is a helpful treatment for people with Alzheimer's disease.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Creatine Monohydrate Arm | Experimental | Dietary Supplement: Creatine MonohydrateThis study a single arm intervention. All participants will receive 20 grams of creatine monohydrate daily for the whole intervention (8 weeks). |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Creatine MonohydrateParticipants 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. | Dietary supplement | Creatine Monohydrate Arm |
Primary outcome
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.
Change in Blood Creatine
Time frame: Baseline, 4 weeks, and 8 weeks
Measure of serum creatine levels at baseline, 4 weeks, and 8 weeks.
5 secondary outcomes
Change in Brain Creatine Status
Time frame: Baseline and 8 weeks
Change in Cognition
Time frame: Baseline and 8 weeks
Change in Peripheral Mitochondrial Respiration
Time frame: Baseline and 8 weeks
Change in Muscle Strength
Time frame: Baseline and 8 weeks
Change in Muscle Size
Time frame: Baseline and 8 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2024.
- Derived from this study: PubMed 41737290K Taylor M, Smith AN, Choi IY, Lee P, Kelly E, Arora T, Sullivan DK, Burns JM, Swerdlow RH, Wilkins HM. Bioenergetic data from a creatine monohydrate pilot trial in Alzheimer's disease. Alzheimers Dement (N Y). 2026 Feb 22;12(1):e70228. doi: 10.1002/trc2.70228. eCollection 2026 Jan-Mar.
- Derived from this study: PubMed 40977987Smith AN, Sullivan DK, Morris JK, Carbuhn AF, Herda TJ, Taylor MK. Eight weeks of creatine monohydrate supplementation is associated with increased muscle strength and size in Alzheimer's disease: data from a single-arm pilot study. Front Nutr. 2025 Sep 4;12:1670641. doi: 10.3389/fnut.2025.1670641. eCollection 2025.
- Derived from this study: PubMed 40395689Smith AN, Choi IY, Lee P, Sullivan DK, Burns JM, Swerdlow RH, Kelly E, Taylor MK. Creatine monohydrate pilot in Alzheimer's: Feasibility, brain creatine, and cognition. Alzheimers Dement (N Y). 2025 May 19;11(2):e70101. doi: 10.1002/trc2.70101. eCollection 2025 Apr-Jun.
- Derived from this study: PubMed 38414003Taylor MK, Burns JM, Choi IY, Herda TJ, Lee P, Smith AN, Sullivan DK, Swerdlow RH, Wilkins HM. Protocol for a single-arm, pilot trial of creatine monohydrate supplementation in patients with Alzheimer's disease. Pilot Feasibility Stud. 2024 Feb 27;10(1):42. doi: 10.1186/s40814-024-01469-5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Taylor, PhD, RD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Creatine Monohydrate in people with Alzheimer's Disease, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to Creatine Monohydrate Intervention (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05383833, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2024.