Home-based Cognitive Treatment and Cognitive Impairment

NCT04889560 | Unknown

• 1 other identifier: Home CoRe 2021
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The prevalence of neurodegenerative diseases is expected to increase over the next years, in parallel with the aging of the world population. Therefore, it is important to identify new methods to prevent, delay or stop the neurodegenerative waterfall responsible for dementia conversion. To date, there is no fully proven pharmacological treatment for cognitive impairment and the available pharmacological treatments have limited efficacy because consist in symptomatic drugs with adverse side effects. On this point, non-pharmacological intervention may represent adjunctive therapy to medications in order to prevent or delay the onset of the cognitive deficits or dementia. Recently we evaluated the effectiveness of a computerized cognitive training (CoRe) in patients with early cognitive impairment. The main goal of the present protocol is to evaluate the efficacy of the home-based version of CoRe (Home CoRe). To this end, mild dementia or early cognitive impairment, and persons with Subjective Cognitive Impairment (SCI) are enrolled and randomly assigned to the experimental group (Home CoRe) or control group (CoRe). All patients are evaluated before (T0) and after (T1) treatment with an exhaustive neuropsychological assessment. Furthermore, follow-up visits are scheduled 6 months (T2) and 12 months (T3) after the end of the treatment.

Conditions

Cognitive Impairment

Keywords

Neurodegenerative disease; Cognitive decline; Non-pharmacological treatments; Cognitive training; Home-based CT

Outcome Measures

Primary Outcomes (2)

• Mini-Mental State Examination (MMSE)

  Global cognitive functioning measured by MMSE. MMSE is a neuropsychological test for the evaluation of intellectual efficiency disorders and the presence of cognitive impairment. The total score is between a minimum of 0 and a maximum of 30 points. A score of 18 or less indicates a severe impairment of cognitive abilities a score between 18 and 24 indicates moderate to mild impairment, a score of 25 is considered borderline, and a score of 26 to 30 indicates cognitive normality.

  Change from T0 to T1, T2 and T3

• Montreal Overall Cognitive Assessment (MoCA)

  Global cognitive functioning measured by MoCA. MoCA is a widely used screening assessment for detecting cognitive impairment. The MoCA test is a 30-point test. Lower score is worst outcome.

  Change from T0 to T1, T2 and T3

Secondary Outcomes (6)

• Beck Depression Inventory - BDI

  Change from T0 to T1, T2 and T3

• Short Form-36 Health Survey - SF-36

  Change from T0 to T1, T2 and T3

• Patient Global Impression of Change - PGIC

  Change from T0 to T1

• Patients Reported Outcome Measures (PROMS)

  Change from T0 to T1

• Number of CT sessions completed

  Change from T0 to T1, T2 and T3

Study Arms (2)

Experimental group

EXPERIMENTAL

Experimental group receives Home CoRe (Home CoRe Group)

Other: Experimental group

Control group

OTHER

Control group receives CoRe software (CoRe Group)

Other: Control group

Interventions

Experimental group OTHER

Home-based version of a computerized cognitive training (CoRe)

Experimental group

Control group OTHER

Computerized cognitive training (CoRe)

Control group

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• presence of mild dementia, mild cognitive impairment; vascular cognitive impairment, subjective cognitive impairment;
• age between 50 and 85 years;
• educational level ≥ 5 years.

You may not qualify if:

• MMSE \< 20
• CRD \> 1
• pre-existing cognitive impairment (e.g. aphasia, neglect);
• severe disturbances in consciousness;
• concomitant severe psychiatric disease or others neurological conditions (e.g. depression and behavioral disorders).

Sponsors & Collaborators

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

Study Sites (1)

Dementia Research Center

Pavia, 27100, Italy

RECRUITING

Related Publications (14)

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  PMID: 21514249 BACKGROUND

• Coyle H, Traynor V, Solowij N. Computerized and virtual reality cognitive training for individuals at high risk of cognitive decline: systematic review of the literature. Am J Geriatr Psychiatry. 2015 Apr;23(4):335-359. doi: 10.1016/j.jagp.2014.04.009. Epub 2014 May 14.

  PMID: 24998488 BACKGROUND

• Hachinski V, Iadecola C, Petersen RC, Breteler MM, Nyenhuis DL, Black SE, Powers WJ, DeCarli C, Merino JG, Kalaria RN, Vinters HV, Holtzman DM, Rosenberg GA, Wallin A, Dichgans M, Marler JR, Leblanc GG. National Institute of Neurological Disorders and Stroke-Canadian Stroke Network vascular cognitive impairment harmonization standards. Stroke. 2006 Sep;37(9):2220-41. doi: 10.1161/01.STR.0000237236.88823.47. Epub 2006 Aug 17.

  PMID: 16917086 BACKGROUND

• Hsu WY, Ku Y, Zanto TP, Gazzaley A. Effects of noninvasive brain stimulation on cognitive function in healthy aging and Alzheimer's disease: a systematic review and meta-analysis. Neurobiol Aging. 2015 Aug;36(8):2348-59. doi: 10.1016/j.neurobiolaging.2015.04.016. Epub 2015 May 1.

  PMID: 26022770 BACKGROUND

• Lampit A, Hallock H, Valenzuela M. Computerized cognitive training in cognitively healthy older adults: a systematic review and meta-analysis of effect modifiers. PLoS Med. 2014 Nov 18;11(11):e1001756. doi: 10.1371/journal.pmed.1001756. eCollection 2014 Nov.

  PMID: 25405755 BACKGROUND

• Livingston G, Sommerlad A, Orgeta V, Costafreda SG, Huntley J, Ames D, Ballard C, Banerjee S, Burns A, Cohen-Mansfield J, Cooper C, Fox N, Gitlin LN, Howard R, Kales HC, Larson EB, Ritchie K, Rockwood K, Sampson EL, Samus Q, Schneider LS, Selbaek G, Teri L, Mukadam N. Dementia prevention, intervention, and care. Lancet. 2017 Dec 16;390(10113):2673-2734. doi: 10.1016/S0140-6736(17)31363-6. Epub 2017 Jul 20. No abstract available.

  PMID: 28735855 BACKGROUND

• Mendonca MD, Alves L, Bugalho P. From Subjective Cognitive Complaints to Dementia: Who is at Risk?: A Systematic Review. Am J Alzheimers Dis Other Demen. 2016 Mar;31(2):105-14. doi: 10.1177/1533317515592331.

  PMID: 26142292 BACKGROUND

• McKhann GM, Knopman DS, Chertkow H, Hyman BT, Jack CR Jr, Kawas CH, Klunk WE, Koroshetz WJ, Manly JJ, Mayeux R, Mohs RC, Morris JC, Rossor MN, Scheltens P, Carrillo MC, Thies B, Weintraub S, Phelps CH. The diagnosis of dementia due to Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement. 2011 May;7(3):263-9. doi: 10.1016/j.jalz.2011.03.005. Epub 2011 Apr 21.

  PMID: 21514250 BACKGROUND

• Prehn K, Floel A. Potentials and limits to enhance cognitive functions in healthy and pathological aging by tDCS. Front Cell Neurosci. 2015 Sep 14;9:355. doi: 10.3389/fncel.2015.00355. eCollection 2015.

  PMID: 26441526 BACKGROUND

• Sachdev PS, Blacker D, Blazer DG, Ganguli M, Jeste DV, Paulsen JS, Petersen RC. Classifying neurocognitive disorders: the DSM-5 approach. Nat Rev Neurol. 2014 Nov;10(11):634-42. doi: 10.1038/nrneurol.2014.181. Epub 2014 Sep 30.

  PMID: 25266297 BACKGROUND

• Bernini S, Alloni A, Panzarasa S, Picascia M, Quaglini S, Tassorelli C, Sinforiani E. A computer-based cognitive training in Mild Cognitive Impairment in Parkinson's Disease. NeuroRehabilitation. 2019;44(4):555-567. doi: 10.3233/NRE-192714.

  PMID: 31256092 RESULT

• Bernini S, Panzarasa S, Barbieri M, Sinforiani E, Quaglini S, Tassorelli C, Bottiroli S. A double-blind randomized controlled trial of the efficacy of cognitive training delivered using two different methods in mild cognitive impairment in Parkinson's disease: preliminary report of benefits associated with the use of a computerized tool. Aging Clin Exp Res. 2021 Jun;33(6):1567-1575. doi: 10.1007/s40520-020-01665-2. Epub 2020 Sep 8.

  PMID: 32895890 RESULT

• Bernini S, Valcarenghi A, Panzarasa S, Quaglini S, Costa A, Ramusino MC, Picascia M, Barbieri M, Tassorelli C, Vecchi T, Bottiroli S. HomeCoRe for telerehabilitation in mild or major neurocognitive disorders: a non-inferiority randomized controlled trial. Geroscience. 2025 Nov 13. doi: 10.1007/s11357-025-02006-9. Online ahead of print.

  PMID: 41225283 DERIVED

• Bernini S, Panzarasa S, Sinforiani E, Quaglini S, Cappa SF, Cerami C, Tassorelli C, Vecchi T, Bottiroli S. HomeCoRe for Telerehabilitation in Mild or Major Neurocognitive Disorders: A Study Protocol for a Randomized Controlled Trial. Front Neurol. 2021 Dec 23;12:752830. doi: 10.3389/fneur.2021.752830. eCollection 2021.

  PMID: 35002919 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction; Neurodegenerative Diseases

Interventions

Control Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Stefano Cappa, Prof

  IRCCS Mondino Foundation, Pavia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara Bottiroli, PhD

CONTACT

0382 380201; sara.bottiroli@mondino.it

Cinzia Fattore, MD

CONTACT

0382 380385; cinzia.fattore@mondino.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single (neuropsychologist for cognitive assessments)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2021
• First Posted: May 17, 2021
• Study Start: June 30, 2021
• Primary Completion: April 30, 2023
• Study Completion: June 30, 2024
• Last Updated: February 9, 2022

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)