Demans Riski Taşıyan Yaşlı Erişkinlerde Bilişsel Bozukluk ve Engelliliği Önlemek için Metformin ve FINGER Girişimi

Sade dilde özet

Bu çalışma, demans (dementia) açısından risk taşıyan yaşlı erişkinlerde, sağlıklı yaşam tarzına dayalı FINGER programı ile metformin ilacının bilişsel bozukluğu önlemeye yardımcı olup olmadığını araştırmaktadır. Çalışmaya, 60-79 yaş arasında, demans risk puanı yüksek ve yaşına göre bilişsel performansı ortalama düzeyde veya biraz altında olan kişiler alınmaktadır. Imperial College London tarafından yürütülen çalışma Faz 2 aşamasında olup halen katılımcı almaktadır.

Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.

Deney bilgileri

Faz

Faz 2 (Phase 2)

Durum

Devam ediyor, katılım kapalı

Sponsor

Imperial College London

Müdahale

FINGER 2.0 multidomain lifestyle-based intervention, Self-guided multidomain lifestyle intervention

Başlangıç

25.01.2023

Tahmini bitiş

30.06.2028

Ülkeler

Finland, Sweden, United Kingdom

İlgili genler

Merkezler

• Helsinki, Finland
• Solna, Sweden
• London, United Kingdom

Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

Inclusion Criteria:

* Main inclusion criteria (all participants)

  1. Age 60-79 years.
  2. Cardiovascular Risk Factors, Aging and Dementia (CAIDE) Risk Score ≥6 points.
  3. Cognitive performance at the mean level or slightly lower than expected for age according to local population norms based on the Montreal Cognitive Assessment (MoCA) test and the Consortium to Establish a Registry for Alzheimer's Disease (CERAD) verbal learning test.
  4. Proficiency in the local language (English, Finnish or Swedish)
* Inclusion criteria for metformin/placebo treatment (only for participants in the FINGER 2.0 multimodal lifestyle-based intervention arm)

  1. No diagnosed diabetes or known contraindications to metformin treatment.
  2. Elevated adiposity (BMI≥25 kg/m2 OR waist circumference \> 102 cm in men and \> 88 cm in women) OR mildly impaired fasting glucose (6.1-6.9 mmol/l).

Exclusion Criteria:

* Main exclusion criteria (all participants)

  1. Dementia or substantial cognitive impairment (e.g., memory clinic referral needed as judged by the study physician).
  2. Current or past use of medications for Alzheimer's Disease or related diseases (e.g., cholinesterase inhibitors, memantine, aducanumab).
  3. Diminished decision-making capacity, not capable of consenting or completing study assessments, based on clinical judgement.
  4. Other known significant neurologic disease (including e.g., Parkinson's disease, Huntington's disease, normal pressure hydrocephalus, brain tumour, progressive, supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma with persistent neurologic sequelae or known structural brain abnormalities).
  5. Any other condition affecting safe engagement in the intervention (e.g., malignant disease, major depression, symptomatic cardiovascular disease, revascularisation within the previous year).
  6. Severe loss of vision, hearing, or communicative ability; conditions preventing cooperation.
  7. Coincident participation in the active phase of another intervention trial.
  8. A member of the household already enrolled in the MET-FINGER trial
* Exclusion criteria for metformin/placebo treatment (only for participants in the FINGER 2.0 multimodal lifestyle-based intervention group)

  1. Use of metformin for any indication.
  2. History of intolerance to metformin used for any indication.
  3. Diabetes diagnosed or suspected at baseline (e.g., HbA1c≥6.5%, fasting glucose ≥7 mmol/l, or 2HPG≥11.1 mmol/l).
  4. Metformin contraindications, e.g., history/presence of known renal or liver disease, congestive heart failure, alcohol abuse, calculated Glomerular Filtration Rate\<60 ml/min.