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
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Condition or disease | Intervention/treatment |
---|---|
Parkinson Disease Dementia | Other: Neuropsychological Assessment |
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 |

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.
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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.
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Ages Eligible for Study: | 65 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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)

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
Contact: Michèle Kiesmann, MD | 33 3 88 11 55 11 | michele.kiesmann@chru-strasbourg.fr |
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 |
Principal Investigator: | Michèle Kiesmann, MD | University Hospital, Strasbourg, France |
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 |