LESCOD: "Lewy Body Screening in Cognitive Disorders"

Alzheimer Disease Clinical Trial

— LESCOD  

Official title:

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"

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02263287
• Other study ID #: RC14_0007
• Status: Terminated
• Phase: N/A
• First received: July 22, 2014
• Last updated: December 5, 2017
• Start date: October 2014
• Est. completion date: August 2017

Study information

• Verified date: December 2017
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 133
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 90 Years

Eligibility

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)

Related Conditions & MeSH terms

• Alzheimer Disease
• Lewy Body Disease

Intervention

Other:
• LeSCoD scale
LeSCoD is a clinical scale

Locations

Country	Name	City	State
France	Nantes University Hospital	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Construct validity of the LeSCoD scale with a factorial analysis	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	Diagnostic validity of the Lescod scale by measuring the sensitivity and the specificity	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	Intergroup variance will be used to assess the quality of the patient denomination	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	Concurrent validity will be assessed by the measurement of the striatal dopaminergic depletion and its correlation with the Lescod score	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)