METformin and FINGER Intervention to Prevent Cognitive Impairment and Disability in Older Adults at Risk for Dementia
NCT05109169, Phase 2, Active not recruiting, Imperial College London
Trial 11
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | METformin and FINGER Intervention to Prevent Cognitive Impairment and Disability in Older Adults at Risk for Dementia | ClinicalTrials.gov |
| NCT number | NCT05109169 | ClinicalTrials.gov |
| Status | Active not recruiting | ClinicalTrials.gov |
| Phases | Phase 2 | ClinicalTrials.gov |
| Enrollment | 600 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Imperial College London | ClinicalTrials.gov |
| Conditions | Cognitive Decline, Cognitive Impairment, Dementia | ClinicalTrials.gov |
| Interventions | FINGER 2.0 multidomain lifestyle-based intervention, Self-guided multidomain lifestyle intervention | ClinicalTrials.gov |
| First posted | 2021-11-05 | ClinicalTrials.gov |
| Last updated | 2026-07-10 | ClinicalTrials.gov |
| Other registries' IDs | eudract:2021-005213-14 | ClinicalTrials.gov |
Registered outcomes 40
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change in cognition, unit on a scale. | Baseline, 12- and 24-months | Composite z-score of an extended Neuropsychological Test Battery (NTB) adapted from the FINGER trial and including: 1. Wechsler Memory Scale Revised (WMS-III, WMS-R) logical memory, immediate 2. WMS-R logical memory, delayed 3. WMS-R visual paired associates, immediate 4. WMS-R visual paired associates, delayed 5. WMS-R Digit Span, total 6. Hopkins Verbal Learning Test (HVLT), learning 7. HVLT, recall 8. CERAD category fluency 9. Category fluency (fruits and vegetables) 10. Trail Making Test (TMT) A 11. TMT B, shifting score B-A 12. Stroop Test, shortened 40-stimulus version, condition 2 13. Stroop Test, condition 3, interference score 3 - 2 14. Wechsler Adult Intelligence Scale (WAIS) Digit Symbol Substitution Test (DSST). The z-score values range from -3 standard deviations to +3 standard deviations of the result distribution with higher score indicating better outcome. | ClinicalTrials.gov |
| Secondary | Change in individual cognitive domains, unit on a scale. | Baseline, 12- and 24-months | Composite z-scores for the: * memory * executive function * processing speed domains that are included in the NTB used as measure for the primary outcome. The z-score values range from -3 standard deviations to +3 standard deviations of the result distribution with higher score indicating better outcome. | ClinicalTrials.gov |
| Secondary | Change in functioning level - Clinical Dementia Rating (CDR), unit on a scale | Baseline, 12- and 24-months | CDR Sum of Boxes (0-18), with lower score indicating a better outcome. | ClinicalTrials.gov |
| Secondary | Change in functioning level - Katz index, unit on a scale | Baseline, 12- and 24-months | Activity of Daily Living, Katz Index. Self-reported questionnaire ranking the independence in six basic daily functions. For each activity, the participant is rated either dependent (0 points) or independent (1 point). The total score ranges 0-6 with a higher score indicating a better outcome. | ClinicalTrials.gov |
| Secondary | Change in functioning level - Lawton-Brody scale, unit on a scale | Baseline, 12- and 24-months | Activity of Daily Living, Lawton-Brody Scale. Self-reported questionnaire assessing the level of functioning in eight daily activities necessary for living in the community. For each activity, the participant is rated either dependent (0 points) or independent (1 point). Score ranges 0-8, with a higher score indicating a better outcome. | ClinicalTrials.gov |
| Secondary | Change in healthy lifestyle, unit on a scale. | Baseline, 12- and 24-months | Healthy Lifestyle Index, a composite score (range 0-24, with higher score indicating a better outcome) including self-reported data on diet, physical activity, smoking and alcohol, and cognitive/social activities. | ClinicalTrials.gov |
| Secondary | Change in systolic blood pressure, mmHg. | Baseline, 12- and 24-months | Lower systolic blood pressure indicates a better outcome. | ClinicalTrials.gov |
| Secondary | Change in diastolic blood pressure, mmHg. | Baseline, 12- and 24-months | Lower diastolic blood pressure indicates a better outcome. | ClinicalTrials.gov |
| Secondary | Change in Body Mass Index (BMI), kg/m2. | Baseline, 12- and 24-months | Calculated using baseline height, with lower BMI value indicating a better outcome. | ClinicalTrials.gov |
| Secondary | Change in waist circumference, cm. | Baseline, 12- and 24-months | Lower value indicates a better outcome, with lower waist circumference value indicating a better outcome. | ClinicalTrials.gov |
| Secondary | Change in waist-hip ratio, unit on a scale. | Baseline, 12- and 24-months | Values ranging up to 1 with lower waist/hip ratio value indicating a better outcome. | ClinicalTrials.gov |
| Secondary | Change in blood lipids - Total Cholesterol, mmol/L. | Baseline, 12- and 24-months | Measured from serum with lower cholesterol value indicating a better outcome. | ClinicalTrials.gov |
| Secondary | Change in blood lipids - HDL Cholesterol, mmol/L. | Baseline, 12- and 24-months | Measured from serum with cholesterol higher value indicating a better outcome. | ClinicalTrials.gov |
| Secondary | Change in blood lipids - LDL Cholesterol, mmol/L. | Baseline, 12- and 24-months | Measured from serum with lower cholesterol value indicating a better outcome. | ClinicalTrials.gov |
| Secondary | Change blood triglycerides, mmol/L. | Baseline, 12- and 24-months | Measured from serum with lower triglycerides value indicating a better outcome. | ClinicalTrials.gov |
| Secondary | Change in plasma glucose, mmol/L | Baseline, 12- and 24-months | Measured from fasting blood sample, with lower glucose value indicating a better outcome. | ClinicalTrials.gov |
| Secondary | Change in glycated haemoglobin (HbA1c), % | Baseline, 12- and 24-months | Measured from fasting blood sample, with lower HbA1c value indicating a better outcome. | ClinicalTrials.gov |
| Secondary | Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR), unit on a scale. | Baseline, 12- and 24-months | Calculated using fasting plasma glucose and fasting serum insulin, with lower values indicating a better outcome. | ClinicalTrials.gov |
| Secondary | Change in 2-hour plasma glucose, mmol/L. | Baseline, 12- and 24-months | Measured with Oral Glucose Tolerance Test, only in participants included in the metformin/placebo treatment, and with lower glucose values indicating a better outcome. | ClinicalTrials.gov |
| Secondary | Change in dietary intake, unit on a scale. | Baseline, 12- and 24-months | FINGER Diet Index, with values ranging 0-9, and higher score indicating a better outcome. | 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 4
The papers the trial lists on ClinicalTrials.gov.
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 7
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 |
|---|---|---|
| Category Fluency | Primary outcome | ConductCognition |
| Digit Span Test | Primary outcome | ConductCognition |
| Short Story Recall | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Symbol Coding | Primary outcome | ConductCognition |
| Trail Making Test B | Primary outcome | ConductCognition |
| Verbal Learning | Primary outcome | ConductCognition |
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.3.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 4a570df2e7274cee2d4fa2959402fab41880e2cd412e4b590390035fbea69391 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
Release trials-2026-11-12-0.3.0
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.