Performance of AclarusDx™, a Blood-Based Transcriptomic Test for AD, in US Patients Newly Referre… (NCT01465360) | Clinical Trial Compass
CompletedNot Applicable
Performance of AclarusDx™, a Blood-Based Transcriptomic Test for AD, in US Patients Newly Referred to a Memory Center
United States160 participantsStarted 2011-11
Plain-language 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.
Who can participate
Age range
21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 disea…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Sensitivity of AclarusDx™ in AD patients
Timeframe: Outcome measured during one single study visit