Predictive Value of Cognitive Tests Performed for the Dia... | NCT01316562

Studies
Predictive Value of Cognitive Tests Performed for the Diagnosis of Alzheimer's Disease and Related Disorders

NCT01316562

Sponsor

University Hospital, Angers

Status

Unknown status

Last Update Posted

Mar 9, 2012Estimated

Enrollment

500Estimated

Phase

Not provided

Conditions

Alzheimer's Disease
Impaired Cognition
Memory Disorders

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2009

Primary Completion Date

Jul 2011Actual

Completion Date

Jul 2012Estimated

First Submitted Date

Mar 11, 2011

First Submission Date that Met QC Criteria

Mar 14, 2011

First Posted Date

Mar 16, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 8, 2012

Last Update Posted Date

Mar 9, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to determine the predictive value of standardized cognitive tests performed in health examination centres for the diagnosis of Alzheimer's disease and related disorders among adults aged 65 years and older with a subjective memory complaint.

Detailed Description

The main objective of this study is to determine the predictive value of standardized cognitive tests performed in health examination centres for the diagnosis of Alzheimer's disease and related disorders among adults aged 65 years and older with a subjective memory complaint.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1		Healthy controls
Group 2		Patients with an Alzheimer's disease or related disorders

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Score of episodic memory and executive psychometric tests		Baseline

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age ≥ 65 years
Community-dwellers
Volunteers receiving a free medical examination in Health examination centre
Subjective memory complaint

Exclusion Criteria:

Known dementia
Sensory deficit compromising the cognitive evaluation
Poor workmanship of the written or oral French language

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

All subjects with memory complaint recruited during a free medical examination in Health examination centres of Lyon, Saint-Etienne and Angers, France

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Bruno Fantino, Professor	Contact	(+33)472513647		bruno.fantino@ces.cnamts.fr

Overall Officials

Name	Affiliation	Role
Bruno Fantino, Professor	CES de Baraban, Lyon	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CES Baraban	Recruiting	Lyon		69456	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26518736	Derived	Vannier-Nitenberg C, Dauphinot V, Bongue B, Sass C, Bathsavanis A, Rouch I, Deville N, Beauchet O, Krolak-Salmon P, Fantino B. Performance of cognitive tests, individually and combined, for the detection of cognitive disorders amongst community-dwelling elderly people with memory complaints: the EVATEM study. Eur J Neurol. 2016 Mar;23(3):554-61. doi: 10.1111/ene.12888. Epub 2015 Oct 30.
23742705

ID	Term
D000544	Alzheimer Disease
D003072	Cognition Disorders
D008569	Memory Disorders

ID	Term
D003704	Dementia
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases