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 @ 7:11 PM
Ignite Modification Date:
2025-12-24 @ 7:11 PM
NCT ID:
NCT03748303
Eligibility Criteria:
Inclusion Criteria:
* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Men or postmenopausal women, aged 55 years or older
* Diagnosis of MCI due to AD or mild AD
* In good general health as evidenced by medical history and with no medical contraindications to participation
* MMSE \> 20 at screen
* Caregiver willing and capable to accompany the patient to clinic visits
Exclusion Criteria:
* Daily use of benzodiazepines, sedative/hypnotics, anticonvulsants, antipsychotics, and other drugs that might interact with the GABA-A receptor complex.
* Seizure disorder, history of stroke, focal brain lesion, traumatic brain injury, substance abuse, malignancy.
* Clinically significant laboratory or ECG abnormality obtained at screening visit.
* MRI indicative of significant abnormality, including but not limited to evidence of a single prior hemorrhage or infarct \>1 cm3, multiple lacunar infarcts (\>1) or evidence of a single prior infarct \>1cm3, evidence of a cerebral contusion, encephalomalacia, aneurysms, vascular malformations, subdural hematoma, or space occupying lesions (e.g. abscess or tumor).
* Has any contraindications for MRI studies, including claustrophobia, the presence of metal (ferromagnetic) implants, or a cardiac pacemaker that is not compatible with MRI.
* Is currently enrolled in a clinical trial involving an off-label use of an investigational drug or device, or concurrently enrolled in any other type of medical research or observational study judged not to be scientifically or medically compatible with this study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
55 Years
Study:
NCT03748303
Study Brief:
Protocol Section:
NCT03748303