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

February 23, 2024 updated by: Consorci Sanitari de l'Alt Penedès i Garraf

Neuropsychological Assessment Of The Non-institutionalized Oldest-Old Population. Multicenter Normative Study.

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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: César Gálvez-Barrón, Ph.D.
  • Phone Number: 0034 626419884
  • Email: cgalvez@csapg.cat

Study Contact Backup

Study Locations

  • Spain
    • Barcelona
      • Sant Pere De Ribes, Barcelona, Spain
        • Recruiting
        • Centro de Salud Les Roquetes-Sant Pere de Ribes
        • Contact:
        • Principal Investigator:
          • Lavinia Vico, M.D.
        • Sub-Investigator:
          • David Vega, M.D.
        • Sub-Investigator:
          • Malva S Cuevas, M.D.
        • Sub-Investigator:
          • Maria Ll Calvet, M.D.
      • Vilanova I La Geltrú, Barcelona, Spain
        • Recruiting
        • Centro de Salud Vilanova i la Geltrú 2 Jaume I
        • Contact:
        • Principal Investigator:
          • Iván Gómez, M.D.
        • Sub-Investigator:
          • Isabel Garro, M.D.
        • Sub-Investigator:
          • Sandra Pons, M.D.
        • Sub-Investigator:
          • Juan Stuart, M.D.
        • Sub-Investigator:
          • Monserrat Marlès, M.D.
      • Vilanova I La Geltrú, Barcelona, Spain
        • Recruiting
        • Centro de Salud Vilanova i la Geltrú 3 Baix A Mar
        • Contact:
        • Principal Investigator:
          • Sara Martínez, M.D.
    • Barcelone
      • Sant Pere De Ribes, Barcelone, Spain, 08810
        • Recruiting
        • Centro de Salud Sant Pere de Ribes
        • Contact:
        • Principal Investigator:
          • Franz Guerrero, MD
        • Sub-Investigator:
          • Vanessa Miguel, MD
        • Sub-Investigator:
          • Gemma Pozuelo, MD
        • Sub-Investigator:
          • Carmen Ferrando, MD
        • Sub-Investigator:
          • José Luis Vallina, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

80 years and older (Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

80 or more years old non-institutionalized residents at Comarca del Garraf, a spanish region located at Barcelona Province, with a total of 112 195 people aged 80 years or more registered at public health system.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Neuropsico-Ger
People aged 80 or more years, non-institutionalized, and without pathologies potentially affecting cognitive status.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive Performance
Time Frame: This outcome will be evaluated at Memory Clinic Unit, following the enrollment visit. The evaluation of this outcome will last approximately 60 minutes.
Cognitive performance will be evaluated by 18 neuropsychological test (quantitative scores) which cover all main cognitive domains (memory and learning, language, perceptual-motor abilities, executive functions and attention).
This outcome will be evaluated at Memory Clinic Unit, following the enrollment visit. The evaluation of this outcome will last approximately 60 minutes.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Consorci Sanitari de l'Alt Penedès i Garraf

Collaborators

Centro de Salud Vilanova i la Geltrú 2 Jaume I, Barcelona, Spain
Centro de Salud Vilanova i la Geltrú 3 Baix A Mar, Barcelona, Spain
Centro de Salud Les Roquetes-Sant Pere de Ribes, Barcelona, Spain
Gerència Territorial Metropolitana Sud, Alt Penedès i Garraf, Barcelona, Spain
Centro de Salud Sant Pere de Ribes, Barcelona, Spain

Investigators

  • Principal Investigator: César Gálvez-Barrón, Ph.D., Consorci Sanitari de l'Alt Penedès i Garraf

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 14, 2023

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

July 28, 2022

First Submitted That Met QC Criteria

July 28, 2022

First Posted (Actual)

August 1, 2022

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 23, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSAPG-23v2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD (without personal identification data) could be shared by requirement from other researchers after the end of the study, and only for research proposels and previous approval of promotor center of the study (CSAPG). Anyway, Spanish and European Union legal policy about data protection will strictly be followed (IPD will not be transferred outside European Union).

IPD Sharing Time Frame

After publication of main results of the study.

IPD Sharing Access Criteria

IPD will be shared only for scientific research purposes and following the Spanish and European Union normative law about data protection. The requirements will be directed to the IP of the study. The IP will evaluate the request to verify and evaluate the data that is requested and the purposes for which it is requested. Next, the IP will transfer the request to the promotor center the study for the final decision.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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