Neuropsychological Assessment of Cognitive Decline in Patients With a Definite Parkinson's Disease - Full Text View

Purpose

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	Intervention
Parkinson Disease Dementia	Other: Neuropsychological Assessment


Study Type:	Observational
Study Design:	Observational Model: Case Control Time Perspective: Prospective
Official Title:	Characteristics of Cognitive Decline During Parkinson's Disease in the Elderly

Resource links provided by NLM:

Genetics Home Reference related topics: Parkinson disease

MedlinePlus related topics: Dementia Health Checkup Parkinson's Disease

U.S. FDA Resources

Further study details as provided by University Hospital, Strasbourg, France:


Estimated Enrollment:	40
Study Start Date:	June 2010
Estimated Study Completion Date:	September 2012
Estimated Primary Completion Date:	August 2012 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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.

Groups/Cohorts

Assigned Interventions

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.

Eligibility


Ages Eligible for Study:	65 Years and older (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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


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
Study First Received:	April 27, 2010
Last Updated:	November 30, 2010

Keywords provided by University Hospital, Strasbourg, France:


Parkinson Disease Dementia Observational Case control Neuropsychological assessment

Additional relevant MeSH terms:


Parkinson Disease Dementia Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases	Nervous System Diseases Movement Disorders Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders

ClinicalTrials.gov processed this record on May 22, 2017