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

NCT01465360 | Completed

• 1 other identifier: EHTAD/003
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 3

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.

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

Outcome Measures

Primary Outcomes (1)

• Sensitivity of AclarusDx™ in AD patients

  The determination of the sensitivity of the test, being the percentage of positive AclarusDx™ calls among referred patients being confirmed clinically as having AD at the Memory Center will be calculated.

  Outcome measured during one single study visit

Study Arms (1)

Study patients

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

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Caucasian patients that are newly referred to a Reference Memory Center with a complaint of memory impairment will be enrolled in the study.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Exonhit: lead

Study Sites (3)

Cleveland Clinic Lou Ruvo Center for Brain Health

Las Vegas, Nevada, 89106, United States

Location

Cleveland Clinic Center for Brain Health - Mellen Center

Cleveland, Ohio, 44195, United States

Location

Cleveland Clinic Senior Care Assessment - Lakewood Hospital

Lakewood, Ohio, 44107, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood samples collected in PAXgene® blood RNA tubes

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction; Dementia, Vascular; Aphasia, Primary Progressive; Mixed Dementias; Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders; Cerebrovascular Disorders; Intracranial Arteriosclerosis; Intracranial Arterial Diseases; Leukoencephalopathies; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Aphasia; Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Charles B. Bernick, MD

  Cleveland Clinic Lou Ruvo Center for Brain Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2011
• First Posted: November 4, 2011
• Study Start: November 1, 2011
• Last Updated: July 6, 2012

Record last verified: 2012-07

Locations

US (3)