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

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ClinicalTrials.gov Identifier: NCT01113242
Recruitment Status : Unknown
Verified November 2010 by University Hospital, Strasbourg, France.
Recruitment status was:  Recruiting
First Posted : April 29, 2010
Last Update Posted : December 1, 2010
Sponsor:
Information provided by:
University Hospital, Strasbourg, France

Study Description
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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
Parkinson Disease Dementia Other: Neuropsychological Assessment

Study Design
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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Characteristics of Cognitive Decline During Parkinson's Disease in the Elderly
Study Start Date : June 2010
Estimated Primary Completion Date : August 2012
Estimated Study Completion Date : September 2012

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Groups and Cohorts
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Group/Cohort 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
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Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with idiopathic PD are issued from an ambulatory following at the department of Geriatrics
Criteria

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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01113242


Contacts
Contact: Michèle Kiesmann, MD 33 3 88 11 55 11 michele.kiesmann@chru-strasbourg.fr

Locations
France
Service de Gériatrie, Hôpital de la Robertsau, Hôpitaux Universitaires de Strasbourg Recruiting
Strasbourg, France, 67091
Contact: Michèle Kiesmann, MD       Michele.Kiesmann@chru-strasbourg.fr   
Contact: , MD         
Sub-Investigator: Georges Kaltenbach, MD         
Sub-Investigator: Thomas Vogel, MD         
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
Principal Investigator: Michèle Kiesmann, MD University Hospital, Strasbourg, France
More Information
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Responsible Party: Christine GEILLER, directeur de la Direction de la Recherche Clinique et des Innovations, University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT01113242     History of Changes
Other Study ID Numbers: 4682
First Posted: April 29, 2010    Key Record Dates
Last Update Posted: December 1, 2010
Last Verified: November 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
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders