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OpenTrials
Completed

NCT Number: NCT01113242

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

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Strasbourg, 67091, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Official study title

Characteristics of Cognitive Decline During Parkinson's Disease in the Elderly

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Apr 29, 2010
Registry last updated
Feb 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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