Clinical Trials Directory

Trials / Unknown

UnknownNCT01041989

Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
1,200 (estimated)
Sponsor
Finnish Institute for Health and Welfare · Other Government
Sex
All
Age
60 Years – 77 Years
Healthy volunteers
Not accepted

Summary

This multi-center (6 sites: Helsinki, Kuopio, Oulu, Seinäjoki, Turku, Vantaa) intervention study aims to prevent cognitive impairment, dementia and disability in 60-77 year old persons at an increased dementia risk. The 2-year multi-domain life-style intervention includes nutritional guidance, exercise, cognitive training, increased social activity, and intensive monitoring and management of metabolic and vascular risk factors. The primary outcome is cognitive impairment measured by a sensitive Neuropsychological Test Battery (NTB), and Stroop and Trail Making tests to capture early cognitive impairment typical for both Alzheimer's disease and vascular dementia. We hypothesize that the multi-domain intervention will reduce cognitive impairment in the study group compared to the control group during the initial 2-year intervention period and reduce dementia incidence after the extended follow-up (until at least 300 participants have developed dementia).

Conditions

Interventions

TypeNameDescription
BEHAVIORALNutritional guidanceIndividual counseling sessions and group meetings will be organized.
BEHAVIORALExerciseGuided muscle strength training and aerobic exercise.
BEHAVIORALCognitive trainingCognitive training will be implemented through 8 group sessions lead by a psychologist and a computer-based cognitive training program available to participants via the internet.
OTHERReduction of vascular risk factorsMonitoring and maintenance of metabolic and vascular risk factors

Timeline

Start date
2009-09-01
Primary completion
2013-12-01
Completion
2025-12-01
First posted
2010-01-05
Last updated
2023-04-19

Locations

5 sites across 1 country: Finland

Source: ClinicalTrials.gov record NCT01041989. Inclusion in this directory is not an endorsement.