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DementiaNEUROPSIC-GRNCT05481749

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

An observational study of Dementia and Cognition Disorders in Old Age, run by Consorci Sanitari de l'Alt Penedès i Garraf at 6 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 80 years and older
Conditions the study is for
Dementia, Cognition Disorders in Old Age
How many people
113 participants
Where
6 sitesSpain
Study dates
14 Feb 2023to 29 Jan 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 80 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Spain6 sites

  • Centro de Salud Les Roquetes-Sant Pere de Ribes

    Sant Pere de Ribes, Barcelona

  • Centro de Salud Sant Pere de Ribes

    Sant Pere de Ribes, Barcelone, 08810

  • Centros de Salud Sitges

    Sitges, Barcelona

  • Centro de Salud Vilanova i la Geltrú 1

    Vilanova i la Geltrú, Barcelona

  • Centro de Salud Vilanova i la Geltrú 2 Jaume I

    Vilanova i la Geltrú, Barcelona

  • Centro de Salud Vilanova i la Geltrú 3 Baix A Mar

    Vilanova i la Geltrú, Barcelona

Other trials in Spain

About this study

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

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.

Read the 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.

Keywords
Geriatric Assessment, Aged, 80 and over, Dementia, Cognition Disorders in Old Age
Medical subject headings
Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05481749
Study groupRoleWhat they receive
Neuropsico-GerPeople aged 80 or more years, non-institutionalized, and without pathologies potentially affecting cognitive status.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: This outcome will be evaluated at Memory Clinic Unit, following the enrollment visit. The evaluation of this outcome will last approximately 60 minutes.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2022
  2. Study start14 Feb 2023
  3. Primary completion29 Jan 2026
  4. Study completion29 Jan 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Cross-sectional
Enrolment
113 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05481749
Sponsor's protocol ID
CSAPG-23v2
Acronym
NEUROPSIC-GR
Status last verified
Oct 2026
First submitted
28 Jul 2022
Last updated
27 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: IPD (without personal identification data) could be shared by requirement from other researchers after the end of the study, and only for research proposels and previous approval of promotor center of the study (CSAPG). Anyway, Spanish and European Union legal policy about data protection will strictly be followed (IPD will not be transferred outside European Union).

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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 Jun 23.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 26353935

  • Beker N, Sikkes SAM, Hulsman M, Schmand B, Scheltens P, Holstege H. Neuropsychological Test Performance of Cognitively Healthy Centenarians: Normative Data From the Dutch 100-Plus Study. J Am Geriatr Soc. 2019 Apr;67(4):759-767. doi: 10.1111/jgs.15729. Epub 2018 Dec 27.

    PubMed 30592018

  • Whittle C, Corrada MM, Dick M, Ziegler R, Kahle-Wrobleski K, Paganini-Hill A, Kawas C. Neuropsychological data in nondemented oldest old: the 90+ Study. J Clin Exp Neuropsychol. 2007 Apr;29(3):290-9. doi: 10.1080/13803390600678038.

    PubMed 17454349

  • Weeks A, Swerissen H, Belfrage J. Issues, challenges, and solutions in translating study instruments. Eval Rev. 2007 Apr;31(2):153-65. doi: 10.1177/0193841X06294184.

    PubMed 17356181

  • del Ser Quijano T, Garcia de Yebenes MJ, Sanchez Sanchez F, Frades Payo B, Rodriguez Laso A, Bartolome Martinez MP, Otero Puime A. [Cognitive assessment in the elderly. Normative data of a Spanish population sample older than 70 years]. Med Clin (Barc). 2004 May 22;122(19):727-40. doi: 10.1157/13062190. Spanish.

    PubMed 15171906

  • Morales JM, Gonzalez-Montalvo JI, Bermejo F, Del-Ser T. The screening of mild dementia with a shortened Spanish version of the "Informant Questionnaire on Cognitive Decline in the Elderly". Alzheimer Dis Assoc Disord. 1995 Summer;9(2):105-11. doi: 10.1097/00002093-199509020-00008.

    PubMed 7662322

  • Lobo A, Ezquerra J, Gomez Burgada F, Sala JM, Seva Diaz A. [Cognocitive mini-test (a simple practical test to detect intellectual changes in medical patients)]. Actas Luso Esp Neurol Psiquiatr Cienc Afines. 1979 May-Jun;7(3):189-202. No abstract available. Spanish.

    PubMed 474231

  • Miranda JP, Valencia RR. English and Spanish Versions of a Memory Test: Word-Length Effects Versus Spoken-Duration Effects. Hispanic Journal of Behavioral Sciences. 1997 May 1;19(2):171-81

Questions about this trial

What is this clinical trial studying?

An observational study of Dementia and Cognition Disorders in Old Age, run by Consorci Sanitari de l'Alt Penedès i Garraf at 6 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05481749, which also lists 38 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.

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