Assessment of cognitive performance in people aged 80 and older
Neuropsychological Assessment Of The Non-institutionalized Oldest-Old Population. Multicenter Normative Study.
Consorci Sanitari de l'Alt Penedès i Garraf · NCT05481749
This study is testing how well people aged 80 and older think and remember by using a series of tests to help understand what is normal for their age group.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 80 Years and up |
| Sex | All |
| Sponsor | Consorci Sanitari de l'Alt Penedès i Garraf (other) |
| Locations | 6 sites (Sant Pere de Ribes, Barcelona and 5 other locations) |
| Trial ID | NCT05481749 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the cognitive performance of individuals aged 80 and older using a set of 18 neuropsychological tests. The study aims to establish normal cognitive limits for this age group, which is often underrepresented in existing assessments. Participants will be randomly selected from five primary care centers and categorized into four age groups. The results may enhance the diagnostic evaluation of cognitive disorders in the oldest-old population by adjusting test scores based on age and education level.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 80 years and older who reside in the Comarca del Garraf and can be transferred to the study center.
Not a fit: Patients with severe cognitive impairment, significant mental illness, or other central nervous system diseases are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic tools for assessing cognitive health in the elderly, potentially leading to better management of dementia and cognitive disorders.
How similar studies have performed: While there have been studies assessing cognitive performance in older populations, this specific approach to defining normal limits for the oldest-old is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Sant Pere de Ribes, Barcelona and 5 other locations
- Centro de Salud Les Roquetes-Sant Pere de Ribes — Sant Pere de Ribes, Barcelona, Spain (RECRUITING)
- Centros de Salud Sitges — Sitges, Barcelona, Spain (RECRUITING)
- Centro de Salud Vilanova i la Geltrú 1 — Vilanova i la Geltrú, Barcelona, Spain (RECRUITING)
- Centro de Salud Vilanova i la Geltrú 2 Jaume I — Vilanova i la Geltrú, Barcelona, Spain (RECRUITING)
- Centro de Salud Vilanova i la Geltrú 3 Baix A Mar — Vilanova i la Geltrú, Barcelona, Spain (RECRUITING)
- Centro de Salud Sant Pere de Ribes — Sant Pere de Ribes, Barcelone, Spain (RECRUITING)
Study contacts
- Principal investigator: César Gálvez-Barrón, Ph.D. — Consorci Sanitari de l'Alt Penedès i Garraf
- Study coordinator: César Gálvez-Barrón, Ph.D.
- Email: cgalvez@csapg.cat
- Phone: 0034 626419884
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Dementia, Cognition Disorders in Old Age, Geriatric Assessment, Aged, 80 and over