TEsting METformin Against Cognitive Decline in HD
NCT04826692, Phase 3, Completed, Instituto de Investigacion Sanitaria La Fe
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | TEsting METformin Against Cognitive Decline in HD | ClinicalTrials.gov |
| NCT number | NCT04826692 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Phase 3 | ClinicalTrials.gov |
| Enrollment | 60 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Instituto de Investigacion Sanitaria La Fe | ClinicalTrials.gov |
| Conditions | Huntington Disease | ClinicalTrials.gov |
| Interventions | Metformin, Placebo | ClinicalTrials.gov |
| First posted | 2021-04-01 | ClinicalTrials.gov |
| Last updated | 2025-09-25 | ClinicalTrials.gov |
Registered outcomes 10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Evaluate the effect of metformin on the scores obtained in different cognitive subtests that make up the Unified Huntington's Disease Rating Scale | Baseline - Week 52 | The tests that make up this subscale are the Symbol Digit Modalities Test. It is a comparative test that is collected throughout the entire trial to assess the progression of cognitive functions in patients. The test has 90 seconds time limit. | ClinicalTrials.gov |
| Primary | Evaluate the effect of metformin on the scores obtained in different cognitive subtests that make up the Unified Huntington's Disease Rating Scale (UHDRS). | Baseline - Week 52 | The tests that make up this subscale are the verbal fluency under phonetic slogan with the letters F, A and S, It is a comparative test that is collected throughout the entire trial to assess the progression of cognitive functions in patients. It consists of four categories of time 0-15; 16-30; 31-45 and 46-60 seconds and both hits and errors are counted. | ClinicalTrials.gov |
| Primary | Evaluate the effect of metformin on the scores obtained in different cognitive subtests that make up the Unified Huntington's Disease Rating Scale (UHDRS). | Baseline - Week 52 | The tests that make up this subscale are words and interference in the Stroop test. The Stroop test was performed to determine selective attention and inhibitory response (selective response to stimuli) to recognize a different stimulus among others. The test involves three kinds of stimuli: three columns of color names printed in black (condition A), three columns with different colors (red, green, blue or black) (condition B), and three columns of color names printed in a color that does not necessarily correspond to the word (for For example, the word "green" printed in blue, (condition C). The 3 parts of the test consist of A. speed of reading the words (names of colors printed in black), B. speed of nomination, the subject must name the colors. C. inhibitory response, called the interference test, where the subject must name the color in which the word with the name of the other color. The test has 45 seconds time limit. | ClinicalTrials.gov |
| Secondary | Evaluate the effect of metformin on motor function in patients with Huntington's disease using the Unified Huntington's Disease Scale Total Motor Score. | Baseline - Visit 1 (Week 0) - Week 26 - Week 52 | The motor function evaluation will include the following exams: Ocular Pursuit (horizontal and vertical), Saccade Initiation (horizontal and vertical), Saccade Velocity (horizontal and vertical), Dystrary, Lingual Protusion, Distonia (trunk and limbs), Korea (face , Mouth, trunk and extremities), Repulsion Test, Finger Tast (right and left), Pronate/ Supinate-Hands (right and left), Luria (palm test), Arm rigidity (right and left), Brady Kinesia-Body, Gait (walking difficulties), Tandem Walking. The initial stage of Huntington's Disease is related to a score greater than 4 on the Unified Huntington's Disease Rating Scale Total Motor Score (UHDRS-TMS) and a total functional capacity (UHDRS-TFC) greater than 8. | ClinicalTrials.gov |
| Secondary | Evaluate the effect of metformin on functional capacity in patients with Huntington´s disease using Unified Huntington's Disease Scale Functional Capacity. | Baseline - Visit 1 (Week 0) - Week 26 - Week 52 | It is evaluated by means of a questionnaire on the following variables: Occupation, Finance, Daily life activities, Domestic Works Level of Care. The initial stage of Huntington's Disease is related to a score greater than 4 on the Unified Huntington's Disease Rating Scale Total Motor Score (UHDRS-TMS) and a total functional capacity (UHDRS-TFC) greater than 8. Where 0 its de worse situation and 3 its normal situation | ClinicalTrials.gov |
| Secondary | Evaluate the effect of metformin on behavioral signs and symptoms in patients with Huntington´s disease using Problem Behaviors Assessment-Short form (PBA-s) | Baseline - Visit 1 (Week 0) - Week 26 - Week 52 | Specifically, will be evaluated on the changes in severity obtained in the items of depressed mood, suicidal ideation, anxiety, irritability, aggressiveness, apathy, persistent behavior and thinking, obsessive-compulsive behavior, delusional ideation, hallucinations, and disorientation. The severity is scored is the 0 (absent) to 4 (severe; almost unbearable for the caregiver) The frequency is scored is the 0 (never / almost never) to 4 (daily / almost daily most of the day) | ClinicalTrials.gov |
| Secondary | Evaluate if there are genetic markers associated to metformin by analysis pharmacogenetic. | Visit 1 (week 0) | Analyze whether there are genetic markers associated with a better (or worse) response to metformin, through pharmacogenetics. The genotype of the patients will be analyzed on this material in a panel of single nucleotide polymorphisms (SNPs), related to the effect of Metformin and other medications that patients may be taking simultaneously. | ClinicalTrials.gov |
| Secondary | Analyze the light chain protein of neurofilaments in peripheral blood. | Visit 1 (week 0) and Visit 8 (Week 56) | Analyze the light chain protein of neurofilaments in peripheral blood, as a circulating biomarker. Biomarker analysis will consist of obtaining information on the concentrations of various proteins, which tend to be released into the bloodstream when there are lesions in the nervous system. | ClinicalTrials.gov |
| Secondary | Evaluate the effect of metformin on the degree of independence in patients with Huntington's disease using the Unified Huntington's Disease Rating Scale Functional assessment and independence assessment. | Baseline - Visit 1 (Week 0) - Week 26 - Week 52 | The scale consists in two parts. The first part is to make a functional evaluation with scored is 0 or 1. The second part evaluate degree of independence with scored the 5% to 100%. | ClinicalTrials.gov |
| Secondary | Evaluate the effect of metformin in patients body with Huntington's disease. | Baseline to Week 52 | Incidence of adverse events and incidence of abnormal laboratory test results, The classification of adverse events will be mild, moderate and serious by medical criteria. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 36
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 8177055 | BACKGROUND | PubMed |
| 8684382 | BACKGROUND | PubMed |
| 8898202 | BACKGROUND | PubMed |
| 9267033 | BACKGROUND | PubMed |
| 10409121 | BACKGROUND | PubMed |
| 11602616 | BACKGROUND | PubMed |
| 11912178 | BACKGROUND | PubMed |
| 14978262 | BACKGROUND | PubMed |
| 15047621 | BACKGROUND | PubMed |
| 15483602 | BACKGROUND | PubMed |
| 15793589 | BACKGROUND | PubMed |
| 16076956 | BACKGROUND | PubMed |
| 17110029 | BACKGROUND | PubMed |
| 17900900 | BACKGROUND | PubMed |
| 18558852 | BACKGROUND | PubMed |
| 19074152 | BACKGROUND | PubMed |
| 19245654 | BACKGROUND | PubMed |
| 19646924 | BACKGROUND | PubMed |
| 21631893 | BACKGROUND | PubMed |
| 22425595 | BACKGROUND | PubMed |
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 3
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Symbol Coding | Primary outcome | ConductCognition |
| Verbal Fluency | Primary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)