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

NCT01113242 | Completed

• 1 other identifier: 4682
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease Dementia

Keywords

Parkinson Disease Dementia; Observational; Case control; Neuropsychological assessment

Study Arms (2)

A:

Patients with idiopathic PD and with MMSE \< à 26

Other: Neuropsychological Assessment

B:

Patients with idiopathic PD and with MMSE ≥ à 26

Other: Neuropsychological Assessment

Interventions

Neuropsychological Assessment OTHER

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.

A:; B:

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with idiopathic PD are issued from an ambulatory following at the department of Geriatrics

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Service de Gériatrie, Hôpital de la Robertsau, Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

Location

MeSH Terms

Interventions

Neuropsychological Tests

Intervention Hierarchy (Ancestors)

Psychological Tests; Behavioral Disciplines and Activities

Study Officials

• Michèle Kiesmann, MD

  University Hospital, Strasbourg, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2010
• First Posted: April 29, 2010
• Study Start: June 1, 2010
• Primary Completion: August 1, 2012
• Study Completion: September 1, 2012
• Last Updated: February 5, 2020

Record last verified: 2010-11

Locations

FR (1)