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 citas
Etiquetas de revisión
Vínculos de autores con la industriaDatos neutrales que nuestra revisión registró sobre cómo se hizo este estudio. Describen el método, nunca si nos gusta el resultado.
Cómo se estudió
- Diseño
- Ensayo clínico controlado (clasificado por nuestro filtro de IA)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiación independiente
- Organización sin fines de lucro
- Alzheimer's Association
- Gobierno
- National Institutes of Health
- Gobierno
- National Institute on Aging
- Gobierno
- NIA NIH HHS
- Organización sin fines de lucro
- Alzheimer's Association
- Autores
- Al menos un autor declara un vínculo económico con la industria
- Subvenciones
- 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)
Según 5 financiadores declarados y la declaración de financiación del texto completo.
Publicación
- Publicado
- 2024-02-27 · Pilot Feasibility Stud · vol. 10 · número 1 · pág. 42
- Editorial
- BioMed Central
- Citado
- 8 citas · más que el 81% de estudios similares · 1.7× el promedio de su campo
- Referencias
- 43 trabajos
- Acceso
- Acceso abierto (revista) · CC-BY
- Áreas de investigación
- Muscle metabolism and nutrition · Nutrition and Health in Aging · Biochemical effects in animals
- Palabras clave
- 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 autores
- Matthew K. Taylor🇺🇸 · autor de correspondenciaUniversity of Kansas; University of Kansas Medical Center
- Jeffrey Murray Burns🇺🇸University of Kansas; University of Kansas Medical Center
- In‐Young Choi🇺🇸University of Kansas Medical Center
- Trent J. Herda🇺🇸University of Kansas
- Phil Lee🇺🇸University of Kansas Medical Center
- Aaron N. Smith🇺🇸University of Kansas Medical Center
- Debra K. Sullivan🇺🇸University of Kansas; University of Kansas Medical Center
- Russell Howard Swerdlow🇺🇸University of Kansas; University of Kansas Medical Center
- Heather Wilkins🇺🇸University of Kansas; University of Kansas Medical Center
Resumen
El texto original del estudio, en el idioma en que se publicó.
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.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial (CC BY).
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