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Recruiting NCT05481749

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

— Observational Dementia Cognition Disorders in Old Age

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Dementia, Cognition Disorders in Old Age. Basic parameters: from 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Primary outcome measures

  • 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.]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

Spain · 6 centers
  • Centro de Salud Les Roquetes-Sant Pere de Ribes — Sant Pere de Ribes
  • Centros de Salud Sitges — Sitges
  • Centro de Salud Vilanova i la Geltrú 1 — Vilanova i la Geltrú
  • Centro de Salud Vilanova i la Geltrú 2 Jaume I — Vilanova i la Geltrú
  • Centro de Salud Vilanova i la Geltrú 3 Baix A Mar — Vilanova i la Geltrú
  • Centro de Salud Sant Pere de Ribes — Sant Pere de Ribes

Publications

  • Hugo J, Ganguli M. Dementia and cognitive impairment: epidemiology, diagnosis, and treatment. Clin Geriatr Med. 2014 Aug;30(3):421-42. doi: 10.1016/j.cger.2014.04.001. Epub 2014 Jun 12. PMID 25037289
  • Slavin MJ, Brodaty H, Sachdev PS. Challenges of diagnosing dementia in the oldest old population. J Gerontol A Biol Sci Med Sci. 2013 Sep;68(9):1103-11. doi: 10.1093/gerona/glt051. Epub 2013 May 17. PMID 23685769
  • Corrada MM, Brookmeyer R, Paganini-Hill A, Berlau D, Kawas CH. Dementia incidence continues to increase with age in the oldest old: the 90+ study. Ann Neurol. 2010 Jan;67(1):114-21. doi: 10.1002/ana.21915. PMID 20186856
  • Helmer C, Peres K, Letenneur L, Guttierez-Robledo LM, Ramaroson H, Barberger-Gateau P, Fabrigoule C, Orgogozo JM, Dartigues JF. Dementia in subjects aged 75 years or over within the PAQUID cohort: prevalence and burden by severity. Dement Geriatr Cogn Disord. 2006;22(1):87-94. doi: 10.1159/000093459. Epub 2006 May 18. PMID 16710088
  • Pena-Casanova J, Blesa R, Aguilar M, Gramunt-Fombuena N, Gomez-Anson B, Oliva R, Molinuevo JL, Robles A, Barquero MS, Antunez C, Martinez-Parra C, Frank-Garcia A, Fernandez M, Alfonso V, Sol JM; NEURONORMA Study Team. Spanish Multicenter Normative Studies (NEURONORMA Project): methods and sample characteristics. Arch Clin Neuropsychol. 2009 Jun;24(4):307-19. doi: 10.1093/arclin/acp027. Epub 2009 J PMID 19549723
  • Bonete Lopez B, Oltra-Cucarella J, Lorente Martinez R, Sitges Macia E. [Normative data of the abbreviated-revised Barcelona test for cognitively active elderly people]. Rev Esp Geriatr Gerontol. 2020 May-Jun;55(3):137-146. doi: 10.1016/j.regg.2019.09.007. Epub 2019 Dec 23. Spanish. PMID 31874774
  • Guardia-Olmos J, Pero-Cebollero M, Rivera D, Arango-Lasprilla JC. Methodology for the development of normative data for ten Spanish-language neuropsychological tests in eleven Latin American countries. NeuroRehabilitation. 2015;37(4):493-9. doi: 10.3233/NRE-151277. PMID 26577889
  • Giulioli C, Meillon C, Gonzalez-Colaco Harmand M, Dartigues JF, Amieva H. Normative Scores for Standard Neuropsychological Tests in the Oldest Old From the French Population-Based PAQUID Study. Arch Clin Neuropsychol. 2016 Feb;31(1):58-65. doi: 10.1093/arclin/acv055. Epub 2015 Sep 8. PMID 26353935

Identifiers

NCT: NCT05481749 · CSAPG-23v2

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗