A Study to Evaluate the Efficacy and Safety of ABBV-8E12 in Participants With Early Alzheimer's Disease

AbbVie

Status and phase: Completed; Phase 2

Conditions: Alzheimer's Disease

Treatments: Drug: placebo for ABBV-8E12; Drug: ABBV-8E12

Study type: Interventional

Funder types: Industry

Identifiers

NCT02880956

2016-001634-10 (EudraCT Number)

M15-566

Details and patient eligibility

About

This study seeks to evaluate the efficacy and safety of ABBV-8E12 in participants with early Alzheimer's disease (AD).

Enrollment: 453 patients

Sex: All

Ages: 55 to 85 years old

Volunteers: No Healthy Volunteers

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

• Subject has any contraindications or inability to tolerate brain magnetic resonance imaging (MRI), PET scans or lumbar puncture.
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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453 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo for ABBV-8E12 every 4 weeks for 96 weeks

Treatment:

Drug: placebo for ABBV-8E12

ABBV-8E12 300 mg

Experimental group

Description:

ABBV-8E12 300 mg every 4 weeks for 96 weeks

Treatment:

Drug: ABBV-8E12

ABBV-8E12 1000 mg

Experimental group

Description:

ABBV-8E12 1000 mg every 4 weeks for 96 weeks

Treatment:

Drug: ABBV-8E12

ABBV-8E12 2000 mg

Experimental group

Description:

ABBV-8E12 2000 mg every 4 weeks for 96 weeks

Treatment:

Drug: ABBV-8E12