A Phase 2 Multiple Dose, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ABBV-8E12 in Subjects with Early Alzheimer's Disease

A Phase 2 Multiple Dose, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ABBV-8E12 in Subjects with Early Alzheimer's Disease - M15-566

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON48538

Enrollment

Registered

2017-10-04

Start date

2018-12-11

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neurologisch Alzheimer's Alzheimers disease

Interventions

Subjects will be randomized to one of the 3 dose arms or placebo in a 1:1:1:1 ratio.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * Subject who meets the National Institute on Aging and the Alzheimer's Association (NIA-AA) clinical criteria for mild cognitive impairment or probable AD, and have: - Clinical Dementia Rating (CDR)-Global Score of 0.5 - Mini-Mental State Examination (MMSE) score of 22 to 30, inclusive - Repeatable Battery for the Assessment of Neuropsychological Status-Delayed Memory Index (RBANS - DMI) score of 85 or lower * Subject has a positive amyloid Positron Emission Tomography (PET) scan. * Subject has a Modified Hachinski Ischemic Scale (MHIS) score of 4. * The subject has an identified, reliable, study partner (e.g., family member). * If using medications to treat symptoms related to AD, doses must be stable for at least 12 weeks prior to randomization.

Exclusion criteria

Exclusion criteria: * Subject has any contraindications or inability to tolerate to brain magnetic resonance imaging (MRI), PET scans or lumbar puncture (optional). * Subject has evidence of any other clinically significant neurological disorder other than Early AD. * In the opinion of the investigator, the subject has any clinically significant or uncontrolled medical or psychiatric illness, or has had an infection requiring medical intervention in the past 30 days. * Subject has had a myocardial infarction, unstable angina, stroke, transient ischemic attack or required intervention for any of these conditions within 6 months of screening Visit 1.

Design outcomes

Primary

Measure	Time frame
Primary endpoint: CDR-SB at week 96.	—

Secondary

Measure	Time frame
Secondary endpoints are determined by various assessments: PK, MMSE, ADAS-Cog-14, RBANS, ADCS-MCI-ADL-24, FAQ, UPSA-B, ADCS-CGIC-MCI. This will be determined at 96 weeks.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)