Performance of AclarusDx™, a Blood-Based Transcriptomic Test for AD, in US Patients Newly Referred to a Memory Center

NCT ID: NCT01465360

Last Updated: 2012-07-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 160 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-11-30

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 impairments.

Detailed Description

The objective of this study is to apply AclarusDx™ signature in a reference US Center in 160 patients newly referred to one of the three study centers within the Cleveland Clinic, Center for Brain Health network, for diagnostic workup. Only AclarusDx™ will be added to the panel of tests usually performed at the centers to establish diagnosis. AclarusDx™ will be used for investigational use only, not for diagnostic purpose. The ultimate goal is to define the clinical utility of AclarusDx™ to provide Primary Care Physicians (PCPs) with a tool that will help them in making the diagnosis of Alzheimer's Disease (AD).

The primary objectives are :

1. To obtain an estimate of the capability of AclarusDx™ to identify AD patients among a US-based population of newly referred patients suffering from objective memory impairment which maybe potentially related to multiple and different etiologies.

2. To compare the performance of AclarusDx™ in a US-based population of newly referred patients with memory impairment with the performance of AclarusDx™ observed in one comparable European population.

Conditions

Alzheimer's Disease; Mild Cognitive Impairment; Vascular Dementia; Fronto-temporal Dementia; Primary Progressive Aphasia; Parkinson' Disease Dementia; Mixed Dementia

Keywords

Alzheimer's disease; AD; Non AD dementia; Mild Cognitive Impairment; MCI; Vascular dementia; Fronto-temporal dementia; Primary progressive aphasia; Parkinson's Disease dementia; Mixed dementia; Blood signature; Diagnosis; AclarusDx; Alzheimer's Disease and other non-AD dementia; Exonhit

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Study patients

Patients newly referred to a Reference Memory Center with a complaint of memory impairment for AD diagnostic workup.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Male or female patient referred to the center for memory impairment.
• The memory impairment has previously been observed by a caregiver or documented by a physician.
• The memory impairment is confirmed by the memory center.
• Caucasian ethnicity.
• A written informed consent approved by an ethical review board or similar body must be obtained from the patient prior to any study-related procedures.
• If applicable, standard treatment with cholinesterase inhibitor and/or memantine is acceptable.
• Patient estimated to be compliant with study procedures.
• Patient has a level of understanding sufficient to agree to all procedures required by the protocol and must be able to cooperate. Under no circumstances will a subject who does not understand the procedure, be allowed to consent to the procedure.

Exclusion Criteria

• Recent acute pathology or medical condition or surgery which may alter the inflammatory homeostasis, according to the opinion of the investigator.
• Non-Caucasian ethnicity.
• Patient with severe uncontrolled or unstable medical condition.
• Need for a legal representative for the medical condition of the patient.
• Any current pathology or medical condition, for which blood sampling may involve a risk for the patient's health, according to the opinion of the investigator.
• Current or recent history (within one month) of clinically significant pathology, medical condition (including hospitalization) or symptoms. However, chronic diseases or medical conditions that are considered stable are accepted, provided that they are compatible with other study selection criteria.
• Current or recent history of drug or alcohol abuse or dependence.
• Current, clinically significant major psychiatric disorder (eg, major depressive disorder) according to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition text revised (DSM-IV TR), or significant symptoms (eg, hallucinations).
• Woman of childbearing potential is not allowed to participate in the study. (A woman of childbearing potential is a woman who is biologically capable of becoming pregnant).
• Current participation in another study using an investigational non-marketed product.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Exonhit

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Charles B. Bernick, MD

Role: PRINCIPAL_INVESTIGATOR

Cleveland Clinic Lou Ruvo Center for Brain Health

Locations

Cleveland Clinic Lou Ruvo Center for Brain Health

Las Vegas, Nevada, United States

Cleveland Clinic Center for Brain Health - Mellen Center

Cleveland, Ohio, United States

Cleveland Clinic Senior Care Assessment - Lakewood Hospital

Lakewood, Ohio, United States

Countries

United States

Other Identifiers

EHTAD/003

Identifier Type: -

Identifier Source: org_study_id