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 @ 1:02 AM
Ignite Modification Date:
2025-12-25 @ 1:02 AM
NCT ID:
NCT01602393
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of amnestic or non-amnestic Mild Cognitive Impairment.
* Mini-Mental State Examination score higher than 24 at screening.
* MRI scan of the brain at screening with fluid-attenuation inversion recovery (FLAIR) and T2\*-weighted gradient-recalled-echo (GRE) sequences.
Exclusion Criteria:
* Diagnosis of Alzheimer's disease according to the (DSM-IV-TR) or NINCDS-ADRDA criteria.
* Any medical condition that could explain the patients cognitive deficits.
* CT or MRI brain imaging results obtained within 12 months prior to baseline showing evidence of infection, infarction, or focal lesions of clinical significance
* MRI scan at screening showing more than 4 cerebral microhemorrhages (lesions with diameter ≤ 10 mm).
* Geriatric Depression Scale (30-point scale) score \> 9 at screening.
* History of stroke.
* Modified Hachinski ischemic scale score \> 4 at screening.
* Women of childbearing potential.
* Vitamin B12 or folate deficiency.
* Diagnosis of schizophrenia or recurrent mood disorder (including unipolar and bipolar disorders) within 3 years of screening.
* Current diagnosis of peptic ulcer or gastrointestinal bleeding within the last year and/or chronic inflammatory bowel disease.
* Concomitant use of donepezil at doses \> 5 mg/day or other cholinesterase inhibitors (rivastigmine or galantamine) at any dose.
* Concomitant use of memantine at dose \> 20 mg/day.
* Concomitant use of psychoactive drugs (sedatives, hypnotics, etc).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
79 Years
Study:
NCT01602393
Study Brief:
Protocol Section:
NCT01602393