Idiopathic Parkinson's Disease: Interest of an Early Group-Based Cognitive Rehabilitation Program (LIFECOG-PD)

NCT07813156 | Not Yet Recruiting

• 2 other identifiers: RBHP 2026 VIDAL2026-A01122-49
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Current pharmacological treatments have not demonstrated significant improvement in cognitive impairment in Parkinson's disease (PD). Given the high prevalence and serious impact of cognitive impairment in PD, there is a pressing need for non-pharmacological interventions with demonstrated functional benefits. Cognitive rehabilitation is a structured program designed to help improve or compensate for patients' cognitive abilities by providing an approach tailored to each patient's individual needs and goals. Neuropsychologists from French Parkinson's Disease expert centers have developed a new cognitive rehabilitation program called LifeCOG-PD, for PD patients with a subjective cognitive complaint or a mild cognitive impairment (MCI), delivered at the hospital in seven 90-minute sessions conducted in groups of 3-4 participants. This program, combining psychoeducation, practical strategies, and personalized goal setting, aims to maintain patients' daily autonomy, enhance quality of life, and delay the cognitive impact of the disease. By evaluating feasibility, acceptability and functional outcomes, this study will contribute critical data to inform future PD management guidelines to help support autonomy and cognitive resilience in PD.

Conditions

Parkinson Disease (PD)

Keywords

parkinson' s disease; cognitive rehabilitation program; subjective cognitive complaint or a mild cognitive impairment; functional autonomy

Outcome Measures

Primary Outcomes (1)

• Proportion of patients completing the 7 sessions of the program

  at the end of the program at 12 weeks

Secondary Outcomes (52)

• Proportion of ineligible participants after screening and inclusion

  at inclusion visit

• Number of participants who withdrew until the end of the program (Dropout rates).

  at the end of the program at 12 weeks

• Perceived level of interest with a satisfaction questionnaire (The Satisfaction with Therapy and Therapist Scale-Revised (STTS-R)

  At the end the program at 12 weeks

• Participants' experience of the program (practical organization of the sessions, understanding and expectations, overall acceptability and recommendations) using qualitative questionnaire

  et the end of the program at 12 weeks

• Perceived benefits of the program as reported by the participant at 3 months post treatment using qualitative questionnaire

  at 24 weeks

Study Arms (1)

cognitive rehabilitation program

EXPERIMENTAL

Patients will receive the new cognitive rehabilitation program.

Other: cognitive rehabilitation program

Interventions

cognitive rehabilitation program OTHER

Patients will receive the program in 7 sessions of 1.5 hours each at their expert centre, spaced 15 days apart, in groups of 3-4 patients. The sessions will address theoretical and practical topics such as working memory and executive functions, attention, and prospective memory in relation to their personal goals.

cognitive rehabilitation program

Eligibility Criteria

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

You may qualify if:

• Men or women ≥18 years old, diagnosed with idiopathic Parkinson's disease according to the official diagnostic criteria defined by the Movement Disorder Society (MDS) ;
• Without cognitive impairment based on neuropsychological evaluation or meeting level 2 Mild Cognitive Impairment (MCI) criteria defined by the MDS, and presenting an early subjective cognitive complaint defined by a score between 1 and 8 on the Subjective Cognitive Complaints Questionnaire for Parkinson's Disease (SCCQ-PD)
• Non-demented according to MDS criteria
• Ability to understand the protocol;
• Ability to provide free and informed consent;
• Patients covered by a social insurance system.

You may not qualify if:

• Any associated neurological disorder or active psychiatric pathology, including severe depressive episode or active psychotic episode. Participants with a Beck Depression Inventory (BDI-II) score above 21 will be excluded from the study and referred to an appropriate healthcare professional for further evaluation and follow-up as needed.
• Patients meeting the criteria for Parkinson's disease dementia
• Any clinical sign suggesting atypical parkinsonian syndrome (ocular motor disorder, cognitive impairment, apraxia, early falls).
• Pregnant or breastfeeding women
• Participants under legal protection measures such as judicial protection, deprivation of liberty, curatorship, or guardianship.

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU de Clermont-Fd

Clermont-Ferrand, 63000, France

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Tiphaine VIDAL

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise LACLAUTRE

CONTACT

+334.73.754.963; promo_interne_drci@chu-clermontferrand.fr

Study Design

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

Study Record Dates

• First Submitted: September 1, 2026
• First Posted: September 10, 2026
• Study Start: September 15, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: September 10, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)