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

Dementia Clinical Trial

— NEUROPSIC-GR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05481749
• Other study ID #: CSAPG-23v2
• Status: Recruiting
• Start date: February 14, 2023
• Est. completion date: March 2025

Study information

• Verified date: February 2024
• Source: Consorci Sanitari de l'Alt Penedès i Garraf
• Contact: César Gálvez-Barrón, Ph.D.
• Phone: 0034 626419884
• Email: cgalvez[@]csapg.cat
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 80 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cognition Disorders
• Cognition Disorders in Old Age
• Dementia

Locations

Country	Name	City	State
Spain	Centro de Salud Les Roquetes-Sant Pere de Ribes	Sant Pere De Ribes	Barcelona
Spain	Centro de Salud Sant Pere de Ribes	Sant Pere De Ribes	Barcelone
Spain	Centro de Salud Vilanova i la Geltrú 2 Jaume I	Vilanova I La Geltrú	Barcelona
Spain	Centro de Salud Vilanova i la Geltrú 3 Baix A Mar	Vilanova I La Geltrú	Barcelona

Sponsors (6)

Lead Sponsor	Collaborator
Consorci Sanitari de l'Alt Penedès i Garraf	Centro de Salud Les Roquetes-Sant Pere de Ribes, Barcelona, Spain, Centro de Salud Sant Pere de Ribes, Barcelona, Spain, 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, Gerència Territorial Metropolitana Sud, Alt Penedès i Garraf, Barcelona, Spain

Country where clinical trial is conducted

Spain, 

References & Publications (38)

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* Note: There are 38 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive Performance	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.