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Background: Metformin has been suggested as a possible strategy for the prevention of Alzheimer disease (AD) and AD related dementias. An early phase II clinical trial of short acting metformin versus placebo showed preliminary evidence of efficacy and safety in slowing cognitive decline among persons with amnestic mild cognitive impairment (aMCI) without diabetes.
Objective: To conduct a phase II/III randomized clinical of extended-release metformin versus placebo in participants with aMCI without diabetes.
Methods: Ratio of 1:1 randomized placebo-controlled trial of extended-release metformin in 326 persons with aMCI without diabetes, aged 55 to 90 years, lasting 18 months, with 4 visits every 6 months including baseline. The primary outcome is changes in total recall in the Free and Cued Selective Reminding Test. Secondary outcomes include (1) changes in global cognitive performance, measured with the Alzheimer Disease Cooperative Study Preclinical Alzheimer Cognitive Composite (ADCS-PACC); (2) changes in neurodegeneration, ascertained as cortical thickness in areas affected by AD on brain MRI; (3) changes in cerebrovascular disease, ascertained as white matter hyperintensities (WMH) volume on brain MRI; (4) changes in whole brain amyloid ß (Aß) SUVR and in incident amyloid positivity; (5) changes in tau SUVR in a composite brain region comprising medial and inferolateral temporal cortex; (6) changes in plasma AD biomarkers.
Conclusion: Observational studies and pilot trials suggest that metformin may help prevent cognitive decline in neurodegenerative disorders. This clinical trial aims to assess metformin's potential in preventing cognitive decline in at-risk individuals and its impact on biomarkers indicative of disease modification.
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http://dx.doi.org/10.1097/WAD.0000000000000677 | DOI Listing |
Trials
August 2025
The University of Queensland, Brisbane, Australia.
Background: Autosomal dominant polycystic kidney disease (ADPKD) is the fourth most common reason for commencement of dialysis globally. There is an urgent need for treatments to slow the loss of kidney function and prevent complications in people with ADPKD. A growing body of evidence suggests metformin may have a therapeutic role in slowing cyst progression in ADPKD.
View Article and Find Full Text PDFDiabetes Obes Metab
September 2025
Yangji Hospital, Seoul, Korea.
Pharmaceutics
May 2025
Department of Pharmaceutical Technology and Biopharmaceutics, Jagiellonian University Medical College, 30-688 Kraków, Poland.
This study delves into the potential use of real-time UV imaging of the dissolution process combined with convolutional neural networks (CNNs) to develop multidimensional models representing the relation between in vitro and in vivo performance of drugs. We utilised the capabilities of the SDi2 apparatus (Pion) to capture multidimensional dissolution data for two distinct Glucophage tablets: immediate-release 500 mg tablets and extended-release 750 mg tablets. The dissolution process was studied in various media, including a compendial pH 1.
View Article and Find Full Text PDFJ Pharm Bioallied Sci
May 2025
Department of Pediatrics, Children's Medical Center of Fresno, Fresno, California, USA.
Background: There is a growing need for safe and effective treatment due to the rise in child obesity rates worldwide. The effectiveness and safety of pediatric obesity drugs were reviewed in this systematic review based on international research.
Techniques: PubMed, Cochrane Library, and Embase searches were performed to locate pediatric randomized controlled trials of antiobesity medications.
J Infect Dis
June 2025
Division of Clinical Pharmacology, Department of Medicine, Stellenbosch University, Cape Town, South Africa.
Background: Obesity among women with HIV (WWH) is nearly 2-fold higher than in men. Obesity is closely associated with dysglycemia, and frequently necessitates the co-administration of dolutegravir and metformin. A pharmacokinetic study in 15 non-obese healthy volunteers determined that dolutegravir increased metformin plasma exposure by 79%, prompting regulatory and guideline recommendations to limit metformin to 1,000 mg/day when co-administered with dolutegravir.
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