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Neuropsychological Assessment of Cognitive Decline in Patients With a Definite Parkinson's Disease

Sponsor
University Hospital, Strasbourg, France (Other)
Overall Status
Completed
CT.gov ID
NCT01113242
Collaborator
(none)
40
Enrollment
1
Location
27
Actual Duration (Months)
1.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Cognitive disorders in Parkinson's disease (PD) are not as obvious as cognitive disorders in Alzheimer disease and their diagnosis tends to be delayed. If neuropsychological assessment of cognitive decline in Parkinson's disease is well established, the thresholds of cognitive testing corresponding to a dementia are unknown. Recently, new diagnosis criteria of dementia associated with PD have been proposed by the movement disorder society. In this study two groups of patients with idiopathic PD will be separated and compared according to their Mini Mental State Examination (MMSE) score (upper or lower than 26). Included patients will have clinically idiopathic PD, will be over 65 years old and will present cognitive complain. Cognitive and mood disorders as well as motor symptoms will be assessed using validated scales and a neuropsychological assessment dispatched in two visits will be performed . Differences in the distribution of data from the two groups of patients will be assessed in statistically analysis with non parametric tests. The purpose of this study is to determine the most effective tests and their threshold value corresponding to a pathological cognitive decline.

Condition or Disease Intervention/Treatment Phase
  • Other: Neuropsychological Assessment

Study Design

Study Type:
Observational
Actual Enrollment :
40 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Characteristics of Cognitive Decline During Parkinson's Disease in the Elderly
Actual Study Start Date :
Jun 1, 2010
Actual Primary Completion Date :
Aug 1, 2012
Actual Study Completion Date :
Sep 1, 2012

Arms and Interventions

Arm Intervention/Treatment
A:

Patients with idiopathic PD and with MMSE < à 26

Other: Neuropsychological Assessment
Included patients had clinically idiopathic PD, were over 65 years old and presented with a cognitive complain. A detailed registration of clinical history (including review of motor, cognitive, and neuropsychiatric symptoms, comorbid medical conditions, and medications) and neurologic examination was performed. Exclusion criteria included other conditions than PD that could contribute substantially to the subject's motor and/or cognitive impairment, including neurologic and major psychiatric disorders ( delirium,…) affecting the cognitive functions. Patients with major cognitive impairment (i.e. Mental State Examination (MMSE) <16/30) were also excluded.). Neuropsychological assessment explores working memory, episodic memory ,verbal fluency, executive functions and visuo constructive functions.
B:

Patients with idiopathic PD and with MMSE ≥ à 26

Other: Neuropsychological Assessment
Included patients had clinically idiopathic PD, were over 65 years old and presented with a cognitive complain. A detailed registration of clinical history (including review of motor, cognitive, and neuropsychiatric symptoms, comorbid medical conditions, and medications) and neurologic examination was performed. Exclusion criteria included other conditions than PD that could contribute substantially to the subject's motor and/or cognitive impairment, including neurologic and major psychiatric disorders ( delirium,…) affecting the cognitive functions. Patients with major cognitive impairment (i.e. Mental State Examination (MMSE) <16/30) were also excluded.). Neuropsychological assessment explores working memory, episodic memory ,verbal fluency, executive functions and visuo constructive functions.

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • MMSE ≥ 16

    • impact of cognitive disorders in daily living

    • criteria of the UKPDSBB for PD

    • steady state in PD

    • benign delusions or treated psychosis are tolerated

    • informed consent obtained

    Exclusion Criteria:

    • dementia from other origin than PD

    • cognitive decline without impact on daily living

    • MMSE < 16

    • delirium in the last 3 months

    • Severe Depression

    • Central Anticholinergic medication

    • inability to perform the cognitive testing

    • major cerebrovascular disease

    • inability to give an informed consent (patients with protective measures)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Service de Gériatrie, Hôpital de la Robertsau, Hôpitaux Universitaires de Strasbourg Strasbourg France 67091

    Sponsors and Collaborators

    • University Hospital, Strasbourg, France

    Investigators

    • Principal Investigator: Michèle Kiesmann, MD, University Hospital, Strasbourg, France

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Strasbourg, France
    ClinicalTrials.gov Identifier:
    NCT01113242
    Other Study ID Numbers:
    • 4682
    First Posted:
    Apr 29, 2010
    Last Update Posted:
    Feb 5, 2020
    Last Verified:
    Nov 1, 2010
    Keywords provided by University Hospital, Strasbourg, France
    Parkinson Disease Dementia
    Observational
    Case control
    Neuropsychological assessment
    Additional relevant MeSH terms:
    Parkinson Disease
    Dementia
    Cognitive Dysfunction

    Study Results

    No Results Posted as of Feb 5, 2020