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NCT Number: NCT07813156

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

This pilot interventional therapeutic study will aim at evaluating the feasibility and acceptability of a new cognitive rehabilitation program designed to preserve autonomy and social roles among early PD MCI patients or isolated subjective cognitive complaint.

24 patients will be enrolled in this study in 5 french centers : Clermont-Ferrand, Bordeaux, Créteil, Nancy and Strasbourg.

The inclusion period is 12 months, and each patient's participation duration is a maximum of 13 months. This study will include 10 visits at the hospital :

  • inclusion visit (during the month preceding the start of the program)
  • 7 sessions of the program (W0, W2, W4, W6, W8, W10, W112)
  • a visit at 24 weeks (3 months after the end of the program)
  • a visit at 48 weeks (9 months after the end of the program)

Patients will receive 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. The neuropsychologist will be blinded from the neuropsychological assessment and the functional goals.

If the patient has a caregiver (spouse or other relative), the investigator may propose them to participate in the study. Their participation will consist of completing a satisfaction questionnaire assessing the perceived benefits of the program for the patient at 3 and 9 months post-program. If they agree, the investigator will obtain their agreement to the collection and use of their data within the framework of this research.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • • 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.

Exclusion criteria

  • • 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.

Treatment and study plan

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.

Primary outcomes

  1. Proportion of patients completing the 7 sessions of the program

    Time frame: at the end of the program at 12 weeks

Secondary outcomes

  1. Proportion of ineligible participants after screening and inclusion

    Time frame: at inclusion visit

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

    Time frame: at the end of the program at 12 weeks

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

    Time frame: At the end the program at 12 weeks

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

    Time frame: et the end of the program at 12 weeks

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

    Time frame: at 24 weeks

  6. Perceived benefits of the program as reported by the participant at 9 months post treatment using qualitative questionnaire

    Time frame: at 48 weeks

  7. Perceived benefits of the program as reported by one of the patient's relatives at 3 months post treatment using qualitative questionnaire

    Time frame: at 24 weeks

  8. Perceived benefits of the program as reported by one of the patient's relatives at 9 months post treatment using qualitative questionnaire

    Time frame: at 48 weeks

  9. Level of achievement of individualized functional goals, assessed using GAS (treated as continuous data transformed by the zscore approach)

    Time frame: at 24 weeks

  10. Level of achievement of individualized functional goals, assessed using GAS (treated as continuous data transformed by the zscore approach)

    Time frame: at 48 weeks

  11. Functional autonomy with the Penn's Parkinson Autonomy Questionnaire-15 items (PDAQ-15)

    Time frame: at inclusion visit

  12. Functional autonomy with the Penn's Parkinson Autonomy Questionnaire-15 items (PDAQ-15)

    Time frame: at 24 weeks

  13. Functional autonomy with the Penn's Parkinson Autonomy Questionnaire-15 items (PDAQ-15)

    Time frame: at 48 weeks

  14. Global subjective cognitive complaints : Subjective Cognitive Complaints Questionnaire for Parkinson's disease (SCCQ-PD)

    Time frame: at inclusion visit

  15. Global subjective cognitive complaints : Subjective Cognitive Complaints Questionnaire for Parkinson's disease (SCCQ-PD)

    Time frame: at 24 weeks

  16. Global subjective cognitive complaints : Subjective Cognitive Complaints Questionnaire for Parkinson's disease (SCCQ-PD)

    Time frame: at 48 weeks

  17. Quality of life using the Parkinson's Disease Questionnaire (PDQ-39)

    Time frame: at inclusion visit

  18. Quality of life using the Parkinson's Disease Questionnaire (PDQ-39)

    Time frame: at 24 weeks

  19. Quality of life using the Parkinson's Disease Questionnaire (PDQ-39)

    Time frame: at 48 weeks

  20. Self-Esteem using the Rosenberg Self-Esteem Scale

    Time frame: at inclusion visit

  21. Self-Esteem using the Rosenberg Self-Esteem Scale

    Time frame: at 24 weeks

  22. Self-Esteem using the Rosenberg Self-Esteem Scale

    Time frame: at 48 weeks

  23. Depressive symptoms using the Beck Depression Inventory II (BDI-II)

    Time frame: at inclusion visit

  24. Depressive symptoms using the Beck Depression Inventory II (BDI-II)

    Time frame: at 24 weeks

  25. Depressive symptoms using the Beck Depression Inventory II (BDI-II)

    Time frame: at 48 weeks

  26. Global cognitive assessment using the Montreal Cognitive Assessment

    Time frame: at inclusion visit

  27. Global cognitive assessment using the Montreal Cognitive Assessment

    Time frame: at 48 weeks

  28. Episodic memory using the 16-items Free and Cued Selective Reminding Test

    Time frame: at inclusion visit

  29. Episodic memory using the 16-items Free and Cued Selective Reminding Test

    Time frame: at 48 weeks

  30. Episodic memory using the Brief Visuospatial Memory Test-R

    Time frame: at inclusion visit

  31. Episodic memory using brief Visuospatial Memory Test-R

    Time frame: at 48 weeks

  32. Attention using Digit Symbol Modalities test

    Time frame: at inclusion visit

  33. Attention using Digit Symbol Modalities test

    Time frame: at 48 weeks

  34. Attention using the Digit Span (Forward and Backward)

    Time frame: at inclusion visit

  35. Attention using digit Span (Forward and Backward)

    Time frame: at 48 weeks

  36. Executive functions using oral Letter-Number Sequencing task

    Time frame: at inclusion visit

  37. Executive functions using oral Letter-Number Sequencing task

    Time frame: at 48 weeks

  38. Executive functions using stroop Color and Word Test D-KEFS

    Time frame: at inclusion visit

  39. Executive functions using stroop Color and Word Test D-KEFS

    Time frame: at 48 weeks

  40. Visuo spatial treatment using the Benton Judgment of Line Orientation Test

    Time frame: at inclusion visit

  41. Visuo spatial treatment using the Benton Judgment of Line Orientation Test

    Time frame: at 48 weeks

  42. Visuo spatial treatment using the clock drawing test

    Time frame: at inclusion visit

  43. Visuo spatial treatment using the clock drawing test

    Time frame: at 48 weeks

  44. Language using the Boston Naming Test (French short form)

    Time frame: at inclusion visit

  45. Language using the Boston Naming Test (French short form)

    Time frame: at 48 weeks

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

    Time frame: at week 0

    at the end of the first session of the program

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

    Time frame: at 2 weeks

    at the end of the session 2 of the program

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

    Time frame: at 4 weeks

    at the end of the session 3 of the program

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

    Time frame: at 6 weeks

    at the end of the session 4 of the program

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

    Time frame: at 8 weeks

    at the end of the session 5 of the program

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

    Time frame: at 10 weeks

    at the end of the session 6 of the program

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

    Time frame: at 12 weeks

    at the end of the session 7 of the program

Study contacts

Contact information is provided by the study sponsor or research team.

Lise LACLAUTRE

CONTACT

[email protected]

+334.73.754.963

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Official study title

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

Acronym: LIFECOG-PD

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 10, 2026
Registry last updated
Sep 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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