Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability

Study Overview
=================
Brief 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).

Official Title
-----------------
Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability

Conditions
-----------------
Cognitive Impairment, Dementia

Intervention / Treatment
-----------------
* Behavioral: Nutritional guidance
* Behavioral: Exercise
* Behavioral: Cognitive training
* Other: Reduction of vascular risk factors


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged 60-77 years dementia Risk Score 6 points or more fulfillment of at least one of the following CERAD criteria: i) MMSE: 20-26 points ii) word list memory task (3x10 words): 19 words or less iii) delayed recall: 75% or less Exclusion Criteria: malignant diseases dementia substantial cognitive decline major depression symptomatic cardiovascular disease revascularisation within 1 year severe loss of vision, hearing or communicative ability other conditions inhibiting from safe engagement in the prescribed intervention as judged by the study physician other conditions preventing from cooperation as judged by the study physician

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 77 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard health counseling at baseline<br> | |
| Experimental: Lifestyle counseling<br>Multi-domain lifestyle counseling including nutritional guidance, increased physical activity, cognitive training, increased social activity and intensive monitoring of vascular and metabolic risk factors. | Behavioral: Nutritional guidance<br>* Individual counseling sessions and group meetings will be organized.<br>Behavioral: Exercise<br>* Guided muscle strength training and aerobic exercise.<br>Behavioral: Cognitive training<br>* Cognitive 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.<br>Other: Reduction of vascular risk factors<br>* Monitoring and maintenance of metabolic and vascular risk factors<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive impairment assessed with a Neuropsychological Test Battery, and Stroop and Trail Making tests. |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depressive symptoms will be assessed using the Zung depression scale. |  | 2 years | 
| Disability will be assessed using the ADCS-ADL scale |  | 2 years | 
| Quality of Life will be assessed using the RAND-36 and 15D questionnaires. |  | 2 years | 
| Utilization of health resources will be assessed using questionnaire and register data. |  | 2 years | 
| Vascular and metabolic risk factors will be assessed with blood pressure and anthropometric measurements, and laboratory analyses of metabolic biomarkers. |  | 2 years | 
| Vascular and metabolic morbidity and mortality will be assessed through questionnaire and register data. |  | 2 years | 
| Changes in dietary biomarker levels will be assessed through laboratory testing. |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
elderly, dementia, cognitive impairment, disability, intervention, lifestyle counseling