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CompletedNCT01113242Updated Feb 5, 2020

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

An observational study in Parkinson Disease Dementia, sponsored by University Hospital, Strasbourg, France. Completed at 1 site in France. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2020-02-05.

Sponsored by University Hospital, Strasbourg, France · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
40
Ages
65 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Parkinson Disease Dementia

Keywords

  • Parkinson Disease Dementia
  • Observational
  • Case control
  • Neuropsychological assessment
03

In context

Lead sponsor

University Hospital, Strasbourg, France is the lead sponsor of 994 studies on the registry; 353 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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)
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
40 participants (actual)

Groups and cohorts

  • 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

  • OtherNeuropsychological 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.

06

Study locations

1 site
  • Service de Gériatrie, Hôpital de la Robertsau, Hôpitaux Universitaires de Strasbourg
    Strasbourg, 67091, France
07

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jun 2010 to primary completion in Aug 2012, 26 months.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 27, 2010
First posted
Apr 29, 2010
StartActual
Jun 2010
Primary completionActual
Aug 2012
CompletionActual
Sep 2012
Last update
Feb 5, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 5, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT01113242
Responsible party
Sponsor
First posted
Apr 29, 2010
Start date
Jun 2010
Primary completion
Aug 2012
Completion
Sep 2012
Last update
Feb 5, 2020

Study contacts

Michèle Kiesmann, MD
principal investigator · University Hospital, Strasbourg, France

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2010. You cannot join it, but the record below documents what was studied.

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