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:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2025-12-24 @ 9:16 PM
NCT ID:
NCT01478204
Eligibility Criteria:
Inclusion Criteria:
* Patients with a recent diagnosis of possible or probable Alzheimer's disease (National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA criteria) within a maximum of 60 days before the baseline visit.
* Patients with mild or moderate Alzheimer's disease, defined by a Mini-Mental State Exam (MMSE) score between 11 and 25.
* Patients whose caregivers are sufficiently informed of the patients' state and if possible live with the patient.
* Patients who are capable of attending a second clinic visit with their accompanying person 3 months later, based on the clinical practice of the investigator.
* Patients and/or legal representatives who have given and signed written informed consent.
Exclusion Criteria:
* Patients who have psychotic manifestations.
* Patients who have clinically significant sleep disorder (sleep apnea syndrome, restless leg syndrome).
* Patients treated with memantine.
* Patients and/or legal representatives who refuse to give written informed consent to participate in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT01478204
Study Brief:
Protocol Section:
NCT01478204