Alzheimer's DiseaseNCT01465360
Performance of AclarusDx™, a Blood-Based Transcriptomic Test for AD, in US Patients Newly Referred to a Memory Center
An observational study of Alzheimer's Disease and Mild Cognitive Impairment, run by Exonhit at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Alzheimer's Disease, Mild Cognitive Impairment, Vascular Dementia
- How many people
- 160 participants
- Where
- 3 sitesUnited States
- Study dates
- Nov 2011to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Cleveland Clinic Center for Brain Health - Mellen Center
Cleveland, Ohio, 44195
Cleveland Clinic Senior Care Assessment - Lakewood Hospital
Lakewood, Ohio, 44107
Cleveland Clinic Lou Ruvo Center for Brain Health
Las Vegas, Nevada, 89106
About this study
Official title: Performance of AclarusDx™, A Blood-Based Transcriptomic Test for Alzheimer's Disease, in US-based Patients Suffering From Memory Impairment and Newly Referred to A Reference Memory Center, for AD Diagnostic Workup-A Pilot Descriptive Study
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.
Read the 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 :
- 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.
- 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
- 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
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction, Dementia, Vascular, Aphasia, Primary Progressive, Mixed Dementias, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study patients | Patients newly referred to a Reference Memory Center with a complaint of memory impairment for AD diagnostic workup. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Outcome measured during one single study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2011 (estimated)
- Study startNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Exonhit
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Charles B. Bernick, MD, Principal investigator, Cleveland Clinic Lou Ruvo Center for Brain Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01465360
- Sponsor's protocol ID
- EHTAD/003
- Status last verified
- Jul 2012
- First submitted
- 28 Oct 2011
- Last updated
- 6 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance of AclarusDx™, A Blood-Based Transcriptomic Test for Alzheimer's Disease, in US-based Patients Suffering From Memory Impairment and Newly Referred to A Reference Memory Center, for AD Diagnostic Workup-A Pilot Descriptive Study
- ClinicalTrials.gov ID
- NCT01465360
- Acronym / sponsor ID
- EHTAD/003
- Conditions
- Alzheimer's Disease, Mild Cognitive Impairment, Vascular Dementia, Fronto-temporal Dementia, Primary Progressive Aphasia, Parkinson' Disease Dementia
- Keywords
- Alzheimer's disease, AD, Non AD dementia, Mild Cognitive Impairment, MCI, Vascular dementia, Fronto-temporal dementia, Primary progressive aphasia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- ExonhitIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- First posted
- 4 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 :
- 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.
- 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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study patients | – | –Patients newly referred to a Reference Memory Center with a complaint of memory impairment for AD diagnostic workup. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensitivity of AclarusDx™ in AD patients
Time frame: Outcome measured during one single study visit
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles B. Bernick, MD principal investigator
Cleveland Clinic Lou Ruvo Center for Brain Health
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer's Disease and Mild Cognitive Impairment, run by Exonhit at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of AclarusDx™ in AD patients (time frame: Outcome measured during one single study visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2012.