Protocol for a single-arm, pilot trial of creatine monohydrate supplementation in patients with Alzheimer's disease
Taylor MK, Burns JM, Choi IY, Herda TJ, Lee P, Smith AN, Sullivan DK, Swerdlow RH, Wilkins HM
Pilot and feasibility studies · 4 citations
Review labels
Neutral facts our review recorded about how this study was done. They describe method, never whether we like the result.
How it was studied
- Design
- Controlled clinical trial (classified by our AI screen)
- Studied in
- People
- Main outcome
- Health markers and function
Who paid for it
- Funding
- Independent funding
- Nonprofit
- Alzheimer's Association
- Government
- National Institutes of Health
- Government
- National Institute on Aging
- Government
- NIA NIH HHS
- Nonprofit
- Alzheimer's Association
- Authors
- At least one author declares a financial tie to industry
- Grants
- National Institute on Aging (P30 AG072973); Alzheimer's Association (AARG-22-924314); National Institute on Aging (K01 AG065487); National Institutes of Health (P30AG072973); National Institutes of Health (K01AG065487)
Based on 5 listed funder(s) and full-text disclosure statement.
Publication
- Published
- 2024-02-27 · Pilot Feasibility Stud · vol. 10 · issue 1 · p. 42
- Publisher
- BioMed Central
- Cited
- 8 citations · more than 81% of similar papers · 1.7× the field average
- References
- 43 works
- Access
- Open access (journal) · CC-BY
- Research areas
- Muscle metabolism and nutrition · Nutrition and Health in Aging · Biochemical effects in animals
- Keywords
- Creatine, Medicine, Bioenergetics, Creatine Monohydrate, Cognition, Internal medicine, Disease, Alzheimer's disease, Effects of sleep deprivation on cognitive performance, Physical therapy, Physical medicine and rehabilitation, Pathology, Placebo, Mitochondrion, Psychiatry, Biology
9 authors
From US
- Matthew K. Taylor · correspondingUniversity of Kansas; University of Kansas Medical Center
- Jeffrey Murray BurnsUniversity of Kansas; University of Kansas Medical Center
- In‐Young ChoiUniversity of Kansas Medical Center
- Trent J. HerdaUniversity of Kansas
- Phil LeeUniversity of Kansas Medical Center
- Aaron N. SmithUniversity of Kansas Medical Center
Abstract
Background
Impaired brain bioenergetics is a pathological hallmark of Alzheimer's disease (AD) and is a compelling target for AD treatment. Patients with AD exhibit dysfunction in the brain creatine (Cr) system, which is integral in maintaining bioenergetic flux. Recent studies in AD mouse models suggest Cr supplementation improves brain mitochondrial function and may be protective of AD peptide pathology and cognition.
Aims
The Creatine to Augment Bioenergetics in Alzheimer's disease (CABA) study is designed to primarily assess the feasibility of supplementation with 20 g/day of creatine monohydrate (CrM) in patients with cognitive impairment due to AD. Secondary aims are designed to generate preliminary data investigating changes in brain Cr levels, cognition, peripheral and brain mitochondrial function, and muscle strength and size.
Methods
CABA is an 8-week, single-arm pilot study that will recruit 20 patients with cognitive impairment due to AD. Participants attend five in-person study visits: two visits at baseline to conduct screening and baseline assessments, a 4-week visit, and two 8-week visits. Outcomes assessment includes recruitment, retention, and compliance, cognitive testing, magnetic resonance spectroscopy of brain metabolites, platelet and lymphocyte mitochondrial function, and muscle strength and morphology at baseline and 8 weeks.
Discussion
CABA is the first study to investigate CrM as a potential treatment in patients with AD. The pilot data generated by this study are pertinent to inform the design of future large-scale efficacy trials.
Trial registration
ClinicalTrials.gov, NCT05383833 , registered on 20 May 2022.
Abstract via Europe PMC. Copyright remains with the authors or publisher (CC BY).
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