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 range21 Years
SexALL
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…
What they're measuring
1
Sensitivity of AclarusDx™ in AD patients
Timeframe: Outcome measured during one single study visit