The Vallecas Project - Early detection of Alzheimer's Disease - JPND Neurodegenerative Disease Research

Title of the cohort

The Vallecas Project – Early detection of Alzheimer’s Disease

Acronym for cohort

VP-EDAD

Name of Principal Investigator

Title	Dr.
First name	Jose L.
Last name	Dobato-Ayuso

Address of institution where award is held

Institution	Research Unit, Alzheimer Center Reina Sofia Foundation
Street Address	Calle de Valderrebollo, 5
City	Madrid
Postcode	28031

Country

Spain

Website

www.fundacioncien.es

Contact email

[email protected]

Funding source

Reina Sofia Foundation
Alzheimer Disease Association (AFAL)
CIEN Foundation

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

Alzheimer’s disease and other dementias

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

Already possible

2a. Stated aim of the cohort

To obtain an algorithm of probability (based on historical, clinical, neuroimaging, and biological data) for calculation of the dementia/AD risk in a 5-year horizon. Pilot study done. Launching: June 2011.

2b. Features distinguishing this cohort from other population cohorts

To identify, in population 70-85 y., the individuals in risk for dementia in few years, based on clinical data, MRI, and blood, using data mining. Aimed at finding a probability, not a marker.

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)

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

This integrator study will provide socio-demographic and clinical data that combined with biological data from blood and MRI will allow to calculate the risk for development of dementia in a few years span. For clinical trials with disease modifiers, this population will be essential (and preferential for treatment).

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

Age in years from:	70
To (‘until death’ if applicable):	85

4b. Study criteria: inclusion criteria

Population 70 to 85 years old, without dementia ot other impairment of mental function interfering with daily life. Subjective memory complaints and mild cognitive impairment are suitable for inclusion.

4c. Study criteria: exclusion criteria

Dementia (any degree) at baseline, or other disorder of mental functions interfering with assessments. Existence of a severe disease impeding long-term follow-up.

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

1,000 – 5,000 participants

6a. Measures used to characterise participants

MMSE, Pfeffer’s FAQ, Visuospatial tests, CDR <1

6b. Additional measures for participants with a clinical disorder

Set Test, Buschke’s Verbal Learning test, Symbol-digit test, Apathy inventory, motor evaluation.
MRI 3T – Volumetry,
Blood- APOE, susceptiblity genes, biochemical determinations

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

7. Study design

Prospective cohort
Longitudinal

8. Cases matched by

Age
Cognitive function

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

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

10a. i) Data collection start date

15-06-2011

10a. ii) Data collection end date

15-06-2017

10a iii) Data collection for this study is

At the planning stage

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

11. Data collected

Only through the study

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
Database is web-based
Database on spreadsheet	Yes
Database is on paper
Other (specify)

Language used:

Spanish

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

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

Language used:

Spanish

14a. Are data available to other groups

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

15. Data sharing policy specified as a condition of use

No policy exists

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
Post-mortem donors: brain

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

Primary samples: Supplied fresh
Primary Samples: Stabilised samples (frozen or fixed)
Secondary samples: derivatives of primary samples
Secondary samples: plasma
Secondary samples: DNA
Secondary samples: RNA
Secondary samples: protein extracts
Secondary samples: cell lines derived from primary samples

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

17. Is information on biological characteristics available to other groups