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 @ 4:17 AM
Ignite Modification Date:
2025-12-25 @ 4:17 AM
NCT ID:
NCT04770220
Eligibility Criteria:
Inclusion Criteria:
* Clinical diagnosis of MCI or Mild Dementia due to AD consistent with the National Institute on Aging-Alzheimer's Association (NIA-AA) Working Group Criteria.
* Homozygous for the ε4 allele of the apolipoprotein E gene (APOE4/4).
* MMSE score at Screening of 22 to 30 (inclusive).
* CDR - Global score of 0.5 or 1 and CDR Memory Box Score of ≥ 0.5.
* RBANS delayed memory index score ≤ 85.
* Evidence of progressive memory loss over the last 12 months per investigator assessment
Exclusion Criteria:
* Brain magnetic resonance imaging (MRI) indicative of significant abnormality per central reader, other than AD related atrophy. Computed tomography (CT) scan acceptable for subjects who cannot undergo MRI.
* Diagnosis of neurodegenerative disorder other than AD.
* Diagnosis of major depressive disorder (MDD) within one year prior to screening.
* Currently taking memantine or has taken memantine within 12 weeks prior to the Baseline Visit.
* History of suicidal behavior within one year prior to screening or has ongoing suicidal ideation.
* History of seizures, excluding febrile seizures of childhood or a single distant seizure (\> 5 years).
* Medically confirmed history of recent cerebral infarct or transient ischemic attack within one year prior to screening.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
80 Years
Study:
NCT04770220
Study Brief:
Protocol Section:
NCT04770220