ClinicalTrials.Veeva

Menu

Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER)

F

Finnish Institute for Health and Welfare

Status

Active, not recruiting

Conditions

Cognitive Impairment
Dementia

Treatments

Behavioral: Exercise
Behavioral: Nutritional guidance
Behavioral: Cognitive training
Other: Reduction of vascular risk factors

Study type

Interventional

Funder types

Other

Identifiers

NCT01041989
THL/TUET 122/2009

Details and patient eligibility

About

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).

Enrollment

1,200 estimated patients

Sex

All

Ages

60 to 77 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

1,200 participants in 2 patient groups

Standard health counseling at baseline
No Intervention group
Lifestyle counseling
Experimental group
Description:
Multi-domain lifestyle counseling including nutritional guidance, increased physical activity, cognitive training, increased social activity and intensive monitoring of vascular and metabolic risk factors.
Treatment:
Other: Reduction of vascular risk factors
Behavioral: Cognitive training
Behavioral: Nutritional guidance
Behavioral: Exercise

Trial contacts and locations

5

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems