Neuropsychological Assessment Of The Oldest-Old Population.(NEUROPSIC-GR)

NCT ID: NCT05481749

Last Updated: 2025-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-14

Study Completion Date

2026-03-31

Brief Summary

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Neuropsychological tests currently considered to evaluate the cognitive performance of the oldest-old population (more than 80 years) are not adapted to this group population. This trial aims to determine the normal limits for this group population of a set of 18 neuropsychological test. Results may improve the diagnostic cognitive evaluation of this population.

Detailed Description

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120 subjects more than 80y old (non-institutionalized) grouped in 4 age categories (80-84, 85-89, 90-94, 95 or more) will be evaluated through 18 neuropsychological tests (usually considered at Memory Clinics).

Subjects will be recruited from 5 Primary Care Centers by a random selection method (stratified by age group).

Normal limits will be defined by the percentiles of test punctuation. Previously, punctuation will be adjusted by age and education level by lineal regression.

Conditions

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Dementia Cognition Disorders in Old Age

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Neuropsico-Ger

People aged 80 or more years, non-institutionalized, and without pathologies potentially affecting cognitive status.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 80 or more years old
* Residence at Comarca del Garraf
* Able to be transfered to study center
* Sufficient reading and writing capacity to carry out the neuropsychological tests, at the evaluator's discretion.

Exclusion Criteria

* Patient at end-of-life situation or with a very short life expectancy (days-weeks).
* Hospital admission in the previous 3 months.
* History of relevant mental illness: major depression, psychosis, bipolar disorder, obsessive-compulsive disorder.
* Disease of the central nervous system with possible cognitive impairment: Parkinson's disease, multiple sclerosis, brain tumor, stroke with cognitive impairment, epilepsy, severe traumatic brain injury.
* History of alcoholism or substance abuse.
* Severe sensory deficit that prevents performing neuropsychological tests, at the discretion of the evaluator.
* Positive Shortened Spanish Informant Questionnaire for Cognitive Decline in the Elderly questionnaire (SS-IQCODE) or Lobo's Cognitive Mini-examination Test (spanish adaptation of Minimental of Folstein test) with a score \< 23 (20 in people with low schooling or illiteracy).
* Dementia criteria according to the Diagnostic and Statistical Manual of Mental Disorders IV.
Minimum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centro de Salud Vilanova i la Geltrú 2 Jaume I, Barcelona, Spain

UNKNOWN

Sponsor Role collaborator

Centro de Salud Vilanova i la Geltrú 3 Baix A Mar, Barcelona, Spain

UNKNOWN

Sponsor Role collaborator

Centro de Salud Les Roquetes-Sant Pere de Ribes, Barcelona, Spain

UNKNOWN

Sponsor Role collaborator

Gerència Territorial Metropolitana Sud, Alt Penedès i Garraf, Barcelona, Spain

UNKNOWN

Sponsor Role collaborator

Centro de Salud Sant Pere de Ribes, Barcelona, Spain

UNKNOWN

Sponsor Role collaborator

Centro de Salud Vilanova i la Geltrú 1 Sant Joan, Barcelona, Spain

UNKNOWN

Sponsor Role collaborator

Centro de Salud Sitges, Barcelona, Spain

UNKNOWN

Sponsor Role collaborator

Consorci Sanitari de l'Alt Penedès i Garraf

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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César Gálvez-Barrón, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Consorci Sanitari de l'Alt Penedès i Garraf

Locations

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Centro de Salud Les Roquetes-Sant Pere de Ribes

Sant Pere de Ribes, Barcelona, Spain

Site Status RECRUITING

Centros de Salud Sitges

Sitges, Barcelona, Spain

Site Status RECRUITING

Centro de Salud Vilanova i la Geltrú 1

Vilanova i la Geltrú, Barcelona, Spain

Site Status RECRUITING

Centro de Salud Vilanova i la Geltrú 2 Jaume I

Vilanova i la Geltrú, Barcelona, Spain

Site Status RECRUITING

Centro de Salud Vilanova i la Geltrú 3 Baix A Mar

Vilanova i la Geltrú, Barcelona, Spain

Site Status RECRUITING

Centro de Salud Sant Pere de Ribes

Sant Pere de Ribes, Barcelone, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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César Gálvez-Barrón, Ph.D.

Role: CONTACT

0034 626419884

Noemi Casaponsa

Role: CONTACT

+34 938960025

Facility Contacts

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Lavinia Vico, M.D.

Role: primary

César Gálvez, PhD

Role: primary

0034938960025

César Gálvez, PhD

Role: primary

0034938960025

Iván Gómez, M.D.

Role: primary

Sara Martínez, M.D.

Role: primary

Franz Guerrero, MD

Role: primary

+34 938962686

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Other Identifiers

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CSAPG-23v2

Identifier Type: -

Identifier Source: org_study_id

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