NCT04826692CompletedPhase 3
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"
Source: ClinicalTrials.gov · Last updated 25 Sept 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 60 (actual)
- First submitted
- 15 Sept 2020
- Start date
- 11 Apr 2022
- Primary completion date
- 10 Jun 2025
- Lead sponsor
- Instituto de Investigacion Sanitaria La Fe
- Diseases
- Huntington's disease
- NCT number
- NCT04826692
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 60
- From 11 Apr 2022 to the primary completion date, 10 Jun 2025
- 9 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- The participant has taken metformin in the last three months before the start of the study.
Other illness
- The participant has diabetes of any kind.
- 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 a serious infection.
- The participant has been treated for heart failure or has recently had a heart attack, has severe circulation problems, or is having difficulty breathing.
- Participants diagnosed with oncological disease.
Lab values
- The participant has kidney problems \[creatinine clearance \<60 ml / min calculated using Cockcroft-Gault formula\] or liver problems.
Other
- The participant is pregnant or lactating.
- The participant is dehydrated, from prolonged or severe diarrhea, or has vomited several times.
- The participant drinks\> 6 units / day of alcohol (alcoholism).
- Participants with a suicidal propensity, with an affirmative answer in items 4 or 5 in the C-SSRS at the screening visit.
Who the study is looking for
- 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%.
- 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.
- They must be trained and will require taking oral medication and will need to be determined to comply with the specific study procedures.
- They must be able to travel to the study center and, in the judgment of the investigator, demonstrate that it is probable that they can continue traveling during the study.
- Availability and willingness of a caregiver, informant, or family member to provide information during study visits that evaluate PBA-s. It is recommended that the caregiver be someone who cares for the patient at least 2 to 3 times a week and at least 3 hours per occasion. The suitability of the caregiver must be judged by the investigator.
Age in the registry: 21 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Complejo Hospitalario de Albacete Coordinator of this site? Confirm its status | Albacete | Spain | Unknown status |
| Hospital General Universitario Dr. Balmis Coordinator of this site? Confirm its status | Alicante | Spain | Unknown status |
| Hospital Universitario Mare de Déu de la Mercé Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital Universitario Burgos Coordinator of this site? Confirm its status | Burgos | Spain | Unknown status |
| Hospital General Universitario de Elche Coordinator of this site? Confirm its status | Elche | Spain | Unknown status |
| Hospital Universitario Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Universitario Central De Asturias Coordinator of this site? Confirm its status | Oviedo | Spain | Unknown status |
| Hospital Universitari Son Espases Coordinator of this site? Confirm its status | Palma de Mallorca | Spain | Unknown status |
| Hospital Universitario Y Politecnico La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.