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)

Baztán JJ, Pérez Del Molino J, Alarcón T, San Cristóbal E, Izquierdo G, Manzarbeitia I. Índice de Barthel: Instrumento válido para la valoración funcional de pacientes con enfermedad cerebrovascular. Rev Esp Geriatr Gerontol. 1993;28:32-40.

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. — View Citation

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. — View Citation

Brown RR, Partington JE. Short Articles and Notes: The Intelligence of the Narcotic Drug Addict. The Journal of General Psychology. 1942 Jan 1;26(1):175-9.

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. — View Citation

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. — View Citation

Della Sala S, Laiacona M, Spinnler H, Trivelli C. Poppelreuter-Ghent's Overlapping Figures Test: its sensitivity to age, and its clinical use. Arch Clin Neuropsychol. 1995 Nov;10(6):511-34. doi: 10.1016/0887-6177(94)00049-v. Erratum In: Arch Clin Neuropsychol. 1996;11(4):359. — View Citation

Dubois B, Slachevsky A, Litvan I, Pillon B. The FAB: a Frontal Assessment Battery at bedside. Neurology. 2000 Dec 12;55(11):1621-6. doi: 10.1212/wnl.55.11.1621. — View Citation

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. — View Citation

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. — View Citation

Harris PA, Taylor R, Minor BL, Elliott V, Fernandez M, O'Neal L, McLeod L, Delacqua G, Delacqua F, Kirby J, Duda SN; REDCap Consortium. The REDCap consortium: Building an international community of software platform partners. J Biomed Inform. 2019 Jul;95:103208. doi: 10.1016/j.jbi.2019.103208. Epub 2019 May 9. — View Citation

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. — View Citation

Hobson P, Meara J, Taylor C. The Weigl Colour-Form Sorting Test: a quick and easily administered bedside screen for dementia and executive dysfunction. Int J Geriatr Psychiatry. 2007 Sep;22(9):909-15. doi: 10.1002/gps.1765. — View Citation

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. — View Citation

Hurtado-Pomares M, Valera-Gran D, Sanchez-Perez A, Peral-Gomez P, Navarrete-Munoz EM, Terol-Cantero MC. Adaptation of the Spanish version of the Frontal Assessment Battery for detection of executive dysfunction. Med Clin (Barc). 2021 Mar 12;156(5):229-232. doi: 10.1016/j.medcli.2020.04.028. Epub 2020 Sep 9. English, Spanish. — View Citation

Ivnik RJ, Malec JF, Smith GE, Tangalos EG, Petersen RC, Kokmen E, et al. Mayo's Older Americans Normative Studies: WAIS-R norms for ages 56 to 97. Clinical Neuropsychologist. 1992;6(Suppl):1-30.

Lawton MP, Brody EM. Assessment of older people: self-maintaining and instrumental activities of daily living. Gerontologist. 1969 Autumn;9(3):179-86. No abstract available. — View Citation

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. — View Citation

Lucas JA, Ivnik RJ, Willis FB, Ferman TJ, Smith GE, Parfitt FC, Petersen RC, Graff-Radford NR. Mayo's Older African Americans Normative Studies: normative data for commonly used clinical neuropsychological measures. Clin Neuropsychol. 2005 Jun;19(2):162-83. doi: 10.1080/13854040590945265. — View Citation

MAHONEY FI, BARTHEL DW. FUNCTIONAL EVALUATION: THE BARTHEL INDEX. Md State Med J. 1965 Feb;14:61-5. No abstract available. — View Citation

Martí D, Miralles R, Llorach I, García-Palleiro P, Esperanza A, Guillem J, et al. Trastornos depresivos en una unidad de convalecencia: experiencia y validación de una versión española de 15 preguntas de la escala de depresión geriátrica de Yesavage. Rev Esp Geriatr Gerontol. 2000 Jan 1;35(1):7-14

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

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. — View Citation

Mungas D, Marshall SC, Weldon M, Haan M, Reed BR. Age and education correction of Mini-Mental State Examination for English and Spanish-speaking elderly. Neurology. 1996 Mar;46(3):700-6. doi: 10.1212/wnl.46.3.700. — View Citation

Ortega G, Alegret M, Espinosa A, Ibarria M, Cañabate P, Boada M. Valoración de las funciones viso-perceptivas y viso-espaciales en la práctica forense. Rev Esp Med Legal. 2014 Apr 1;40(2):83-5

Osterrieth PA. Le test de copie d'une figure complexe; contribution à l'étude de la perception et de la mémoire. [Test of copying a complex figure; contribution to the study of perception and memory.]. Archives de Psychologie. 1944;30:206-356

Pauker JD. Constructing overlapping cell tables to maximize the clinical usefulness of normative test data: rationale and an example from neuropsychology. J Clin Psychol. 1988 Nov;44(6):930-3. doi: 10.1002/1097-4679(198811)44:63.0.co;2-h. — View Citation

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. — View Citation

Quinones-Ubeda S, Pena-Casanova J, Bohm P, Gramunt-Fombuena N, Comas L. [Preliminary normative data for the second edition of the Boston Naming Test for young Spanish adults]. Neurologia. 2004 Jun;19(5):248-53. Spanish. — View Citation

Ramier AM, Hecaen H. [Respective roles of frontal lesions and lesion lateralization in "verbal fluency" deficiencies]. Rev Neurol (Paris). 1970 Jul;123(1):17-22. No abstract available. French. — View Citation

Ramirez M, Ostrosky-Solis F, Fernandez A, Ardila-Ardila A. [Semantic verbal fluency in Spanish-speaking people: a comparative analysis]. Rev Neurol. 2005 Oct 16-31;41(8):463-8. Spanish. — View Citation

Rey A. L'examen psychologique dans les cas d'encéphalopathie traumatique. (Les problems.). [The psychological examination in cases of traumatic encepholopathy. Problems.]. Archives de Psychologie. 1941;28:215-85

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. — View Citation

Stroop JR. Studies of interference in serial verbal reactions. Journal of Experimental Psychology. 1935;18(6):643-62

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. — View Citation

Weiner MF, Hynan LS, Rossetti H, Falkowski J. Luria's three-step test: what is it and what does it tell us? Int Psychogeriatr. 2011 Dec;23(10):1602-6. doi: 10.1017/S1041610211000767. Epub 2011 May 4. — View Citation

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. — View Citation

World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013 Nov 27;310(20):2191-4. doi: 10.1001/jama.2013.281053. No abstract available. — View Citation

* 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.