TEsting METformin Against Cognitive Decline in HD (NCT04826692) | Clinical Trial Compass
CompletedPhase 3
TEsting METformin Against Cognitive Decline in HD
Spain60 participantsStarted 2022-04-11
Plain-language 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).
Who can participate
Age range
21 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Symptomatic positive clinical diagnosis of Huntington disease.
. Presence of 36 CAG repeats (or more) in the hunting gene based on centralized CAG analysis.
. Men or women between 21-65 years of age, inclusive, with an onset of HD at 18 years of age or older.
. Women of childbearing potential (women who are not postmenopausal children or who have not undergone surgical sterilization at times) will need to be using a contraceptive method for 30 days before beginning study treatment, and will have contact with at least two methods of birth control throughout the duration of the study and up to 30 days after taking the last dose of treatment.
. A sum of \> 4 points on the UHDRS-TMS scale and a diagnostic confidence level of 4.
. Scale of independence ≥ 75%.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evaluate the effect of metformin on the scores obtained in different cognitive subtests that make up the Unified Huntington's Disease Rating Scale
Timeframe: Baseline - Week 52
2
Evaluate the effect of metformin on the scores obtained in different cognitive subtests that make up the Unified Huntington's Disease Rating Scale (UHDRS).
Timeframe: Baseline - Week 52
3
Evaluate the effect of metformin on the scores obtained in different cognitive subtests that make up the Unified Huntington's Disease Rating Scale (UHDRS).
. Score on the UHDRS-TFC scale ≥ 8 at the screening visit.
. They must be trained and willing to provide written informed consent prior to any procedure related to the study to be performed at the screening visit. Patients with a legal guardian must be determined according to local requirements.
Exclusion criteria
. The participant has taken metformin in the last three months before the start of the study.
. The participant has diabetes of any kind.
. The participant is pregnant or lactating.
. The participant has a medical condition other than HD (metabolism, kidney function, liver function, heart problems, etc.), or any contraindication against metformin.
. The participant has an uncontrolled psychiatric condition.
. Participant is allergic to metformin or any of the other ingredients of this medicine.
. The participant has kidney problems \[creatinine clearance \<60 ml / min calculated using Cockcroft-Gault formula\] or liver problems.
. The participant is dehydrated, from prolonged or severe diarrhea, or has vomited several times.