Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Dementia

Title of the cohort

Acronym for cohort

FINGER

Name of Principal Investigator

Title	MD, PhD, Associate Professor
First name	Miia
Last name	Kivipelto

Address of institution where award is held

Institution	Aging Research Center, Karolinska Institutet
Street Address
City	Stockholm
Postcode	11330

Country

Sweden

Website

www.thl.fi/finger

Contact email

[email protected]

Funding source

1) Academy of Finland
2) Swedish Research Council (VR)
3) Alzheimer Association
4) Novo Nordisk
5) La Carita foundation

1. The cohort includes, or expects to include, incidence of the following conditions

Alzheimer’s disease and other dementias
Neurodegenerative disease in general

When studies on the above condition(s) are expected to become possible

2011 – 2015

2a. Stated aim of the cohort

To study the effect of the multi-domain lifestyle intervention on cognitive impairment and incidence of dementia/AD

2b. Features distinguishing this cohort from other population cohorts

This is one of the very few large multi-domain randomized controlled trials primarily designed to prevent cognitive impairment. In the control arm it will be possible to study the natural history of cognitive impairment and the role of biomarkers in predicting AD.

3a. i) Number of publications that involve use of cohort to date

3a. ii) Up to three examples of studies to date (PI, Institution, Title of Study)

The intervention is still ongoing

3b. Publication list/link to where data or publications are accessible (if available)

3c. Information (i.e. research findings) expected to be gained from the population cohort

The study will answer to the question to what extend an intensive lifestyle intervention (diet, physical activity, cognitive training, social activity, management of vascular risk factors) can prevent cognitive impairment and AD. Also several secondary outcomes are includes including depressive signs, vascular risk factors and morbidity, disability, quality of life, utilization of health resources, and thus, the total benefit can be investigated. Several biomarkers will be studied and neuroimaging will be conducted for a sub-sample giving possibility to investigate underlying mechanisms. The study is expected to produce both high-qualitative scientific results and means to translate them to clinical practice.

4a. Study criteria: age range of participants at recruitment

Age in years from:	60
To (‘until death’ if applicable):	77

4b. Study criteria: inclusion criteria

Elevated Dementia Risk Score (Kivipelto et al, Lancet Neurology 2006) and cognitive performance slightly lower than expected for age

4c. Study criteria: exclusion criteria

Dementia and significant cognitive impairment, severe illness, medical and other conditions preventing participation in the intervention

5. Size of the cohort (i.e. number of participants enrolled)

1,000 – 5,000 participants

6a. Measures used to characterise participants

Health and lifestyle questionnaire, neuropsychological tests, physical examination, scales for depression, disability, quality of life. Diagnoses of dementia and AD. Blood samples. MRI and PET for a subsample.

6b. Additional measures for participants with a clinical disorder

Differential diagnosis for dementia including MRI, CSF, more detailed neuropsychological tests etc

6c. Are there defined primary and secondary endpoints (e.g. defined health parameters)

Neuropsychological test battery, incidence of dementia and AD

7. Study design

Prospective cohort
Other (please specify)
Randomized controlled trial

8. Cases matched by

9a. Does the study include a specialised subset of control participants

9b. If yes, description of specialised subset of control participants

This is a representative population-based sample. Age and sex matched persons from the control group are used for neuroimaging sub-study

10a. i) Data collection start date

01-09-2009

10a. ii) Data collection end date

10a iii) Data collection for this study is

Data collection ongoing

10b. Plans to continue the cohort study beyond the current projected end date

Yes – intend to apply for funding

11. Data collected

Only through the study
Through links to medical records

12. System in place to enable re-contact with patients for future studies

Yes (participants have given permission to be re-contacted via the PIs to ask if they would participate in further studies)

13a. Format and availability of data stored in a database

	Yes/No	% available
Data summarised in database	yes	40
Database is web-based
Database on spreadsheet
Database is on paper
Other (specify)

Language used:

English

13b. Format and availability of data held as individual records

	Yes/No	% available
Data held as individual records	yes
Data is web-based	yes
Data held on computer based records
Data held on cards
Other (specify)

Language used:

English

14a. Are data available to other groups

Yes

14b. Access policy/mechanisms for access if data are available to other groups

Apply to PI or co-ordinator at resource
Access through collaboration with PI only

15. Data sharing policy specified as a condition of use

No requirement to make data publicly available

16a. Are tissues/samples/DNA available to other groups

Yes

16b. i) Description of available tissues/samples/DNA

Living donors:blood
Living donors: blood derivatives
Living donors: DNA
Living donors: cerebro-spinal fluid

16b. ii) Form available tissues/samples/DNA are supplied in

16b. iii) Is the access policy/mechanism for obtaining samples the same as that for obtaining data

Yes

17. Is information on biological characteristics available to other groups

Yes, for all the cohort