NCT04826692

TEsting METformin Against Cognitive Decline in HD

"Randomized, Double-blind, Placebo-controlled Study to Assess the Effect of Metformin, an Activator of AMPK, on Cognitive Measures of Progression in Huntington's Disease Patients"

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Instituto de Investigacion Sanitaria La Fe · Academic / Other
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Multicenter, randomized, double-blind, placebo-controlled, parallel group study to assess the efficacy and safety of metformin treatment at a dose of 1700 mg / day in adults with Huntington's disease. The study consists of a screening period (2 to 4 weeks), followed by a 52-week double-blind treatment period and a follow-up visit (one month after the end of treatment).

Detailed description

Multicenter, randomized, double-blind, placebo-controlled, parallel group study to assess the efficacy and safety of treatment with metformin at a dose of 1700 mg / day in adults with HD. A total recruitment of 60 patients is expected, which will be randomized in a 1: 1 ratio. 30 patients will receive metformin 1700 g / day, or placebo, for 52 weeks. Patients will begin taking low doses of metformin, to facilitate tolerance and decrease intestinal discomfort. Half the daily dose (425 mg twice daily) will be administered over four weeks, along with the main meals. Patients who tolerate this dose well will continue with treatment by taking 850mg twice daily. Patients who don´t tolerate the initial dose (425 mg twice daily) will be withdrawn from the study.

Conditions

• Huntington Disease

Interventions

Type	Name	Description
DRUG	Metformin	Metformin oral: 425 mg twice daily (initial dose) and 850 twice daily (maximum dose)
DRUG	Placebo	425 mg twice daily (initial dose) and 850 twice daily (maximum dose)

Timeline

• Start date: 2022-04-11
• Primary completion: 2025-06-10
• Completion: 2025-06-10
• First posted: 2021-04-01
• Last updated: 2025-09-25

Locations

9 sites across 1 country: Spain