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 @ 2:08 AM
Ignite Modification Date:
2025-12-25 @ 2:08 AM
NCT ID:
NCT04149860
Eligibility Criteria:
Inclusion criteria
Healthy Participants:
-Men and women ≥18 and ≤65 years of age with a body mass index (BMI) ≥18 and ≤32 kilograms (kg)/square meter (m\^2) and a minimum weight of 50 kg.
Participants with Alzheimer's disease:
* Men and women with a clinical diagnosis of Alzheimer's disease, Stages 3-4 according to the FDA guidelines.
* Mini-Mental State Examination (MMSE) of 15-30.
* Clinical Dementia Scale (CDR) global score up to and including 2.0.
* Confirmed or determined (via amyloid positron emission tomography \[PET\] scan) to be amyloid positive.
* If on FDA approved Alzheimer's disease medication, the treatment has been stable for 4 months prior to Day 1.
-≥50 years of age.
* BMI ≥18 and ≤40 kg/m\^2 and a minimum weight of 50 kg.
Exclusion criteria:
* Clinically relevant structural brain abnormality as assessed using magnetic resonance imaging (MRI).
* Any past or current treatment with an anti-Abeta or anti-tau active vaccine.
* Any past or current treatment with a monoclonal anti-tau antibody or a tau anti-sense oligomer within the last 6 months.
* Treatment with covid-19, influenza or pneumonia vaccine within the last 30 days prior to dosing of investigational medicinal product (IMP).
Other eligibility criteria may apply.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04149860
Study Brief:
Protocol Section:
NCT04149860