Clinical trial NCT05481749: Neuropsychological Assessment Of The Oldest-Old Population.(NEUROPSIC-GR)
Official title: Neuropsychological Assessment Of The Non-institutionalized Oldest-Old Population. Multicenter Normative Study.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Dementia
Cognition Disorders in Old Age
Keywords: Geriatric Assessment
Aged, 80 and over
Dementia
Cognition Disorders in Old Age
Lead sponsor: Consorci Sanitari de l'Alt Penedès i Garraf
Sponsor class: OTHER
Collaborators: name: Centro de Salud Vilanova i la Geltrú 2 Jaume I, Barcelona, Spain
name: Centro de Salud Vilanova i la Geltrú 3 Baix A Mar, Barcelona, Spain
name: Centro de Salud Les Roquetes-Sant Pere de Ribes, Barcelona, Spain
name: Gerència Territorial Metropolitana Sud, Alt Penedès i Garraf, Barcelona, Spain
name: Centro de Salud Sant Pere de Ribes, Barcelona, Spain
First posted: 2022-08-01
Enrollment: 120
Sex: ALL
Minimum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cognitive Performance
timeFrame: This outcome will be evaluated at Memory Clinic Unit, following the enrollment visit. The evaluation of this outcome will last approximately 60 minutes.
Secondary outcomes:
Other outcomes:
Locations:
city: Sant Pere De Ribes
country: Spain
facility: Centro de Salud Les Roquetes-Sant Pere de Ribes
state: Barcelona
city: Vilanova I La Geltrú
country: Spain
facility: Centro de Salud Vilanova i la Geltrú 2 Jaume I
state: Barcelona
city: Vilanova I La Geltrú
country: Spain
facility: Centro de Salud Vilanova i la Geltrú 3 Baix A Mar
state: Barcelona
city: Sant Pere De Ribes
country: Spain
facility: Centro de Salud Sant Pere de Ribes
state: Barcelone
Study officials:
affiliation: Consorci Sanitari de l'Alt Penedès i Garraf
name: César Gálvez-Barrón, Ph.D.
role: PRINCIPAL_INVESTIGATOR
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