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 @ 4:30 AM
Ignite Modification Date:
2025-12-25 @ 4:30 AM
NCT ID:
NCT01324518
Eligibility Criteria:
Inclusion Criteria:
* Informed consent obtained from the patient and legally acceptable representative, if required
* Informed consent obtained from the caregiver
* Males and and females between 55-90 years
* Diagnosis of probable Alzheimer's disease, history of progressive cognitive deterioration
* Brain imaging consistent with Alzheimer's disease
* Mini-mental state examination score 12-21
* Treated with donepezil, rivastigmine or galantamine
* At least mild level of behavioral symptoms
Exclusion Criteria:
* Other types of dementias
* Modified Hachinski Ischemia Score \> 4
* Use of memantine, antipsychotics, anticholinergic medication and benzodiazepines (at a max of 3 nights/week) within 2 months
* Changes in antidepressant dosing within 2 months
* Use of other psychotropic agents
* Myocardial infarction within the past 2 years
* Malignancy within the past 5 years
* Suicidal ideation, risk of suicide
* History of alcoholism or drug abuse within 5 years
* Clinically significant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, neurological or psychiatric disorder or any other major concurrent illness
* Specific findings in brain imaging
* Abnormal findings in heart rate, blood pressure, ECG, laboratory tests, physical examination; orthostatic hypotension
* Blood donation or participation in a drug study within 60 days
* Previous AD immunotherapy treatment
* Patient cannot complete the computerised cognitive training
* Patients who reside in a skilled nursing facility
* Patients who are not able to swallow capsules
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
55 Years
Maximum Age:
90 Years
Study:
NCT01324518
Study Brief:
Protocol Section:
NCT01324518