Case-Finding for Neurocognitive Disorders in Pavia

NCT06983119 | Recruiting

• 1 other identifier: CDCD-RICORDARE_2024
• Study Type: interventional
• Target: 490
• Locations: 1 country
• Sites: 1

Brief Summary

Dementia is a global public health challenge with a heavy caregiving burden, impacting families, communities, and healthcare systems. It is a priority in healthcare planning, with focus on early diagnosis and ongoing support. This research project addresses the global public health challenge posed by dementia, focusing on early detection and comprehensive care. The research evaluates the clinical, social, and healthcare impact of two dementia-related projects in Italy:

1. 1.the first "Ricor-Dare," aims to create an integrated network for identifying new cases of dementia or Mild Cognitive Impairment (MCI) and providing care to patients and caregivers;
2. 2.the second involves establishing a new Center for Cognitive Disorders and Dementia (CCDD) in an area previously lacking such services.

Conditions

Dementia; Mild Cognitive Impairment

Keywords

Case-finding; Dementia; Mild Cognitive Impairment; Memory Clinic; Center for Cognitive Disorders and Dementia; Non-pharmacological intervention; Caregiver; Burden

Outcome Measures

Primary Outcomes (1)

• Effects of the case-finding strategy for the early detection of dementia in its prodromal or initial stages.

  The number of individuals, from the three case-finding settings, diagnosed at the CCDD with Mild Cognitive Impairment (MCI) or dementia within 26 months following assessment at case-finding compared to the total number of people identified as positive cases through GPcog and/or ACE-III and assessed within the three different case-finding settings.

  Up to 26 months

Secondary Outcomes (6)

• The impact of the new CCDD on clinical care in an area that previously lacked such services.

  Up to 26 months

• Patient and caregiver satisfaction with accessing the new CCDD.

  Up to 26 months

• The impact of the diagnostic-care pathway for caregivers at CCDD and "Ricor-Dare" project.

  Up to 26 months

• The impact of the "Dementia Operations Center (COD)" pathway of the "Ricor-Dare" project.

  Up to 26 months

• The impact of education activities on dementia promoted by the "Ricor-Dare" project.

  Up to 26 months

Study Arms (1)

Detection of people reporting cognitive concerns

OTHER

Other: Case-finding for Neurocognitive Disorders

Interventions

Case-finding for Neurocognitive Disorders OTHER

The intervention targets individuals reporting cognitive concerns without a prior diagnosis of MCI or dementia, with participants accessing three different settings for evaluation. The first setting involves General Practitioner (GP) offices, where GPs, trained in dementia risk factors and cognitive assessment tools (such as GPcog), will identify at-risk patients and refer them for further evaluation at a Center for Cognitive Disorders and Dementia (CCDD). The second setting is the Dementia Operations Center (COD) Information Desk, a public service where neuropsychologists assess citizens who independently report cognitive disturbances. The third setting includes Open Days, public events aimed at detecting early signs of cognitive decline, where neuropsychologists will assess participants using the Addenbrooke's Cognitive Examination-III (ACE-III) and the LIBRA Index. Individuals identified as at-risk in any of the three settings will be referred for further evaluation at a CCDD.

Detection of people reporting cognitive concerns

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 50 or older
• Assessment conducted using GPcog/ACE-III depending on the setting
• No prior diagnosis of cognitive decline
• Ability to understand the study objectives and sign an informed consent

You may not qualify if:

• Age under 50
• Presence of a diagnosis of cognitive decline
• Limited knowledge of the Italian language
• Patient:
• All patients/people who are included in one of the actions provided through the "Ricor-Dare" Project or who are attending a visit scheduled in the clinical-care pathway of the CDCD Fondazione Mondino Pavia or Lomellina;
• Ability to understand the aims of the study and to sign an informed consent
• Caregiver:
• Age equal to or greater than 18 years
• Informal caregiver of a family member with a suspected or confirmed diagnosis of dementia who is included in one of the actions provided through the "Ricor-Dare" project or who are attending a visit scheduled in the clinical-care pathway of the CDCD;
• Acceptance of informed consent and voluntary participation in the study.
• Healthcare professionals:
• All healthcare and social healthcare professionals (GPs, pharmacists, nurses, nurses auxiliary) who practice in the cities of Pavia and Vigevano who participate in the project and agree to undergo assessments and training;
• Acceptance of informed consent and voluntary participation in the study.
• Patient:
• \- Inability to understand the aims of the study and to sign an informed consent

Sponsors & Collaborators

• IRCCS National Neurological Institute "C. Mondino" Foundation: lead

Study Sites (1)

IRCCS National Neurological Institute "C. Mondino" Foundation

Pavia, Pavia, 27100, Italy

RECRUITING

Related Publications (11)

• Shanahan N, Orrell M, Schepers AK, Spector A. The development and evaluation of the DK-20: a knowledge of dementia measure. Int Psychogeriatr. 2013 Nov;25(11):1899-907. doi: 10.1017/S1041610213001142. Epub 2013 Aug 15.

  PMID: 23947900 BACKGROUND

• Pucciarelli G, Savini S, Byun E, Simeone S, Barbaranelli C, Vela RJ, Alvaro R, Vellone E. Psychometric properties of the Caregiver Preparedness Scale in caregivers of stroke survivors. Heart Lung. 2014 Nov-Dec;43(6):555-60. doi: 10.1016/j.hrtlng.2014.08.004. Epub 2014 Sep 18.

  PMID: 25239706 BACKGROUND

• Chattat R, Cortesi V, Izzicupo F, Del Re ML, Sgarbi C, Fabbo A, Bergonzini E. The Italian version of the Zarit Burden interview: a validation study. Int Psychogeriatr. 2011 Jun;23(5):797-805. doi: 10.1017/S1041610210002218. Epub 2010 Dec 16.

  PMID: 21205379 BACKGROUND

• Pigliautile M, Chiesi F, Stablum F, Rossetti S, Primi C, Chiloiro D, Federici S, Mecocci P. Italian version and normative data of Addenbrooke's Cognitive Examination III. Int Psychogeriatr. 2019 Feb;31(2):241-249. doi: 10.1017/S104161021800073X. Epub 2018 Jul 19.

  PMID: 30021668 BACKGROUND

• Franchini F, Musicco M, Ratto F, Storti G, Shofany J, Caltagirone C, Di Santo SG. The LIBRA Index in Relation to Cognitive Function, Functional Independence, and Psycho-Behavioral Symptoms in a Sample of Non-Institutionalized Seniors at Risk of Dementia. J Alzheimers Dis. 2019;72(3):717-731. doi: 10.3233/JAD-190495.

  PMID: 31640092 BACKGROUND

• Pirani A, Brodaty H, Martini E, Zaccherini D, Neviani F, Neri M. The validation of the Italian version of the GPCOG (GPCOG-It): a contribution to cross-national implementation of a screening test for dementia in general practice. Int Psychogeriatr. 2010 Feb;22(1):82-90. doi: 10.1017/S104161020999113X. Epub 2009 Nov 6.

  PMID: 19891815 BACKGROUND

• Banerjee S, Wittenberg R. Clinical and cost effectiveness of services for early diagnosis and intervention in dementia. Int J Geriatr Psychiatry. 2009 Jul;24(7):748-54. doi: 10.1002/gps.2191.

  PMID: 19206079 BACKGROUND

• Steiner GZ, Ee C, Dubois S, MacMillan F, George ES, McBride KA, Karamacoska D, McDonald K, Harley A, Abramov G, Andrews-Marney ER, Cave AE, Hohenberg MI. "We need a one-stop-shop": co-creating the model of care for a multidisciplinary memory clinic with community members, GPs, aged care workers, service providers, and policy-makers. BMC Geriatr. 2020 Feb 11;20(1):49. doi: 10.1186/s12877-019-1410-x.

  PMID: 32046657 BACKGROUND

• Prince M, Bryce R, Albanese E, Wimo A, Ribeiro W, Ferri CP. The global prevalence of dementia: a systematic review and metaanalysis. Alzheimers Dement. 2013 Jan;9(1):63-75.e2. doi: 10.1016/j.jalz.2012.11.007.

  PMID: 23305823 BACKGROUND

• Sachdev PS, Lipnicki DM, Kochan NA, Crawford JD, Thalamuthu A, Andrews G, Brayne C, Matthews FE, Stephan BC, Lipton RB, Katz MJ, Ritchie K, Carriere I, Ancelin ML, Lam LC, Wong CH, Fung AW, Guaita A, Vaccaro R, Davin A, Ganguli M, Dodge H, Hughes T, Anstey KJ, Cherbuin N, Butterworth P, Ng TP, Gao Q, Reppermund S, Brodaty H, Schupf N, Manly J, Stern Y, Lobo A, Lopez-Anton R, Santabarbara J; Cohort Studies of Memory in an International Consortium (COSMIC). The Prevalence of Mild Cognitive Impairment in Diverse Geographical and Ethnocultural Regions: The COSMIC Collaboration. PLoS One. 2015 Nov 5;10(11):e0142388. doi: 10.1371/journal.pone.0142388. eCollection 2015.

  PMID: 26539987 BACKGROUND

• Bacigalupo I, Mayer F, Lacorte E, Di Pucchio A, Marzolini F, Canevelli M, Di Fiandra T, Vanacore N. A Systematic Review and Meta-Analysis on the Prevalence of Dementia in Europe: Estimates from the Highest-Quality Studies Adopting the DSM IV Diagnostic Criteria. J Alzheimers Dis. 2018;66(4):1471-1481. doi: 10.3233/JAD-180416.

  PMID: 30412486 BACKGROUND

Related Links

• WHO (2021) Global Status report in the public health response to dementia
• Istat 2024
• Gauthier S, Rosa-Neto P, Morais JA, \& Webster C. (2021) World Alzheimer Report 2021, Abridged version: journey through the diagnosis of dementia. London, England: Alzheimer's Disease International.

MeSH Terms

Conditions

Dementia; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Study Officials

• Alfredo Costa, MD

  IRCCS National Neurological Institute "C. Mondino" Foundation

  STUDY DIRECTOR

Central Study Contacts

Nicola Allegri, PhD

CONTACT

0039 0381692413; nicola.allegri@mondino.it

Alessia Rosi, PhD

CONTACT

0039 0381692413; alessia.rosi@mondino.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2025
• First Posted: May 21, 2025
• Study Start: July 11, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)