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Taylor 2024 Pilot Feasibility Stud

From Bioblast
Publications in the MiPMap
Taylor MK, Burns JM, Choi IY, Herda TJ, Lee P, Smith AN, Sullivan DK, Swerdlow RH, Wilkins HM (2024) Protocol for a single-arm, pilot trial of creatine monohydrate supplementation in patients with Alzheimer's disease. Pilot Feasibility Stud 10:42. https://doi.org/10.1186/s40814-024-01469-5

» PMID: 38414003 Open Access

Taylor Matthew K, Burns Jeffrey M, Choi In-Young, Herda Trent J, Lee Phil, Smith Aaron N, Sullivan Debra K, Swerdlow Russell H, Wilkins Heather M (2024) Pilot Feasibility Stud

Abstract: 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.

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.

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.

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. Keywords: Alzheimer’s disease, Bioenergetics, Brain, Creatine, Pilot trial Bioblast editor: Plangger M O2k-Network Lab: US KS Kansas City Swerdlow RH, US KS Kansas City Wilkins H


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2024-03