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

Recruiting

• Conditions: Dementia; Cognition Disorders in Old Age

• Registration Number: NCT05481749
• Lead Sponsor: Consorci Sanitari de l'Alt Penedès i Garraf

Brief Summary

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

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 Timeline

• Study First Submitted: 2022-07-28
• Study First Submitted QC: 2022-07-28
• Study First Posted: 2022-08-01
• Study Start: 2023-02-14
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-23
• Last Update Posted: 2024-02-28
• Primary Completion: 2025-03
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cognitive Performance	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).

Trial Locations

Locations (4)

Centro de Salud Vilanova i la Geltrú 3 Baix A Mar; 🇪🇸 Vilanova I La Geltrú, Barcelona, Spain

Centro de Salud Vilanova i la Geltrú 2 Jaume I; 🇪🇸 Vilanova I La Geltrú, Barcelona, Spain

Centro de Salud Sant Pere de Ribes; 🇪🇸 Sant Pere De Ribes, Barcelone, Spain

Centro de Salud Les Roquetes-Sant Pere de Ribes; 🇪🇸 Sant Pere De Ribes, Barcelona, Spain