Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-25 @ 2:03 AM
NCT ID:
NCT01465360
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT01465360
Study Brief:
Protocol Section:
NCT01465360