NCT02221661

Brief Summary

The purpose of this study is to assess the performance of AclarusDx™, an investigational blood test detecting gene expression information, and intended to help physicians in making an Alzheimer's Disease diagnosis in patients having memory complaint and/or cognitive impairments.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
606

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2011

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 19, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 20, 2014

Completed
Last Updated

August 22, 2014

Status Verified

August 1, 2014

Enrollment Period

2 years

First QC Date

August 19, 2014

Last Update Submit

August 21, 2014

Conditions

Cognitive ImpairmentMemory ComplaintClinical Investigation in Memory Centers

Keywords

Alzheimercognitive impairmentblood test

Outcome Measures

Primary Outcomes (1)

  • Estimation of the prevalence of positive AclarusDx™ among patients clinically AD diagnosed

    The primary outcome is to estimate the prevalence of positive AclarusDx Alzheimer patients diagnosed (excluding MCI). The prevalence is estimated as a percentage calculated among patients being confirmed clinically as having AD at the Memory Center and having a positive or negative AclarusDx™ result

    Outcome measured during one single study visit

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with cognitive impairment and/or memory complaint justifying a first clinical investigation for diagnosis

You may qualify if:

  • male and female adult patients
  • suffering from cognitive impairment and/or memory complaint and justifying a first clinical investigation at the memory center

You may not qualify if:

  • patient already followed up by the memory center
  • patient unable to comply with study procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood samples collected in PAXgene® blood RNA tubes

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
12 Months
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2014

First Posted

August 20, 2014

Study Start

December 1, 2011

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

August 22, 2014

Record last verified: 2014-08