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

Phase 2

Completed

• Conditions: eurologisch; Alzheimer's; Alzheimer's disease

• Registration Number: NL-OMON48538
• Lead Sponsor: AbbVie B.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2021-02-16
• Results First Posted: 2022-07-05
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 7

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 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint: CDR-SB at week 96.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints are determined by various assessments: PK, MMSE,<br /><br>ADAS-Cog-14, RBANS, ADCS-MCI-ADL-24, FAQ, UPSA-B, ADCS-CGIC-MCI. This will be<br /><br>determined at 96 weeks.</p><br>