LESCOD: "Lewy Body Screening in Cognitive Disorders" (LESCOD)

December 5, 2017 updated by: Nantes University Hospital

LESCOD: "A Single Center, Prospective Study Aimed at Validating a Clinical Scale, Screening for Symptoms of Lewy Body Disease in Patients Incipient Dementia of the Alzheimer's and/or Lewy Body Type"

Dementia with Lewy body (DLB) is the second most common neurodegenerative dementia in autopsy series. However, DLB represents a small proportion of the clinical diagnoses in epidemiology registries. Indeed Alzheimer disease (AD) and DLB are often concomitant, they share many symptoms and only a small weight is given to non-motor symptoms in DLB diagnosis. DLB is at the end of a pathological spectrum overlapping with AD, explaining the poor diagnostic value of both diagnostic criteria. To date there is still a need for a tool able to discriminate patients with pure DLB from those expressing common signs with both AD and DLB and those with pure AD. The purpose of this study is to validate a semi quantitative scale designed to reflect the Lewy Bodies burden in patients with mild to moderate cognitive decline. The investigators hypothesized that the score obtained may differentiate between AD, DLB and patients fulfilling clinical criteria for both DLB an AD. This score could also be correlated with dopaminergic depletion assessed with [18F]fluorodopa PET/computed tomography and/or with potential biomarkers of ADD measured in cerebrospinal fluid. This clinical validation is a preliminary work preceding further studies correlating the LeSCoD score with functional imaging features, prognosis and therapeutic response. Thus, the expected outcomes involve an improvement in demented patients' care, as well as a better patient selection for further therapeutic studies

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

133

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nantes, France
        • Nantes University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

58 years to 88 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Be a woman or a male >60 to < 90 years
  • Have sufficient visual and auditory acuity
  • Be able to speak, read, hear and understand french language
  • Be covered by health care insurance
  • Have a reliable help/partner/informant/caregiver
  • Have a mild to severe cognitive decline based on MMSE (Mini-Mental State Examination) score ( From 18 to 26)
  • Give oral agreement to the assessment of the LEsCoD scale during routine consultation
  • Have performed neuropsychology tests and MRI respectively within 6 and 12 months

Exclusion Criteria:

  • Has evidence of neurological or psychiatric disorder other than AD or DLB explaining cognitive decline
  • Has received previously or currently neuroleptic treatment
  • Has no reliable help/caregiver the day of the visit
  • Refuses to give his/her oral agreement to the assessment of the LeSCoD scale
  • Has presence on MRI of radiologic evidence of cerebrovascular disease (score Fazekas 2)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Alzheimer disease (AD)
Patients with AD according to NINCDS-ADRDA (National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association) criteria Intervention: LeSCoD scale
Other: LeSCoD scale
LeSCoD is a clinical scale
Other: Dementia with Lewy Bodies (DLB)
Patients with probable DLB according to McKeith criteria. Intervention: LeSCoD scale
Other: LeSCoD scale
LeSCoD is a clinical scale
Other: Probable AD and possible DLB
Patients with clinical criteria for possible or probable AD and possible DLB Intervention: LeSCoD scale
Other: LeSCoD scale
LeSCoD is a clinical scale

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Construct validity of the LeSCoD scale with a factorial analysis
Time Frame: Day 0 (during the inclusion visit)
The study consists in one single mandatory visit and 2 optional visits. The clinical scale is performed during the inclusion visit which corresponds to a routine consultation scheduled at the memory clinic
Day 0 (during the inclusion visit)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic validity of the Lescod scale by measuring the sensitivity and the specificity
Time Frame: Day 0 (During the inclusion visit)
The study consists in one single mandatory visit and 2 optional visits. The clinical scale is performed during the inclusion visit which corresponds to a routine consultation scheduled at the memory clinic
Day 0 (During the inclusion visit)
Intergroup variance will be used to assess the quality of the patient denomination
Time Frame: Day 0 (during the inclusion visit)
The study consists in one single mandatory visit and 2 optional visits. The clinical scale is performed during the inclusion visit which corresponds to a routine consultation scheduled at the memory clinic
Day 0 (during the inclusion visit)
Concurrent validity will be assessed by the measurement of the striatal dopaminergic depletion and its correlation with the Lescod score
Time Frame: Day 0 (during the inclusion visit)
The study consists in one single mandatory visit and 2 optional visits. The clinical scale is performed during the inclusion visit which corresponds to a routine consultation scheduled at the memory clinic
Day 0 (during the inclusion visit)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Investigators

  • Study Chair: Sarah EVAIN, Doctor, Nantes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2014

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

July 22, 2014

First Submitted That Met QC Criteria

October 8, 2014

First Posted (Estimate)

October 13, 2014

Study Record Updates

Last Update Posted (Actual)

December 7, 2017

Last Update Submitted That Met QC Criteria

December 5, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC14_0007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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