Creatine to Augment Bioenergetics in Alzheimer's

NCT05383833 | Completed

• 1 other identifier: 148507
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Change in Brain Creatine Status

  Baseline and 8 weeks

• Change in Cognition

  Baseline and 8 weeks

• Change in Peripheral Mitochondrial Respiration

  Baseline and 8 weeks

• Change in Muscle Strength

  Baseline and 8 weeks

• Change in Muscle Size

  Baseline and 8 Weeks

Study Arms (1)

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).

Dietary Supplement: Creatine Monohydrate

Interventions

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.

Creatine Monohydrate Arm

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• Alzheimer's Association: collaborator

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Related Publications (3)

• Smith 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.

  PMID: 40977987 DERIVED

• Smith 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.

  PMID: 40395689 DERIVED

• Taylor 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.

  PMID: 38414003 DERIVED

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Creatine

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Guanidines; Amidines; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Matthew Taylor, PhD, RD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 20, 2022
• First Posted: May 20, 2022
• Study Start: December 12, 2022
• Primary Completion: May 14, 2024
• Study Completion: May 14, 2024
• Last Updated: August 14, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)