A Study to Evaluate the Efficacy and Safety of ABBV-8E12 in Subjects With Early Alzheimer's Disease
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ClinicalTrials.gov Identifier: NCT02880956 |
Recruitment Status
:
Recruiting
First Posted
: August 26, 2016
Last Update Posted
: March 9, 2018
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Alzheimer's Disease | Drug: ABBV-8E12 Drug: placebo for ABBV-8E12 | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 400 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Actual Study Start Date : | October 17, 2016 |
Estimated Primary Completion Date : | December 16, 2020 |
Estimated Study Completion Date : | April 7, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: Group 2
Dose 2 ABBV-8E12
|
Drug: ABBV-8E12
ABBV-8E12 (20 mg/mL) solution for IV infusion
|
Experimental: Group 3
Dose 3 ABBV-8E12
|
Drug: ABBV-8E12
ABBV-8E12 (20 mg/mL) solution for IV infusion
|
Experimental: Group 1
Dose 1 ABBV-8E12
|
Drug: ABBV-8E12
ABBV-8E12 (20 mg/mL) solution for IV infusion
|
Placebo Comparator: Group 4
Placebo for ABBV-8E12
|
Drug: placebo for ABBV-8E12
placebo solution for IV infusion
|
- Adverse Events [ Time Frame: 112 weeks ]
- Clinical Dementia Rating - Sum of Boxes (CDR-SB) [ Time Frame: Week 96 ]A scale used to quantify the severity of symptoms of dementia.
- University of California's Performance Based Skills Assessment, Brief Version (UPSA-Brief) [ Time Frame: 96 weeks ]A performance-based instrument which uses a series of tasks and role-play scenarios to evaluate a person's functional capacity in two areas of basic living skills (i.e., financial skills and communication skills).
- Serum concentration at the end of a dose interval (Ctrough) for ABBV-8E12 [ Time Frame: 96 weeks ]
- Area under the concentration time curve (AUC) for ABBV-8E12 [ Time Frame: 16 weeks ]
- Time to Cmax (Tmax) for ABBV-8E12 [ Time Frame: 16 weeks ]
- Maximum observed serum concentration (Cmax) for ABBV-8E12 [ Time Frame: 16 weeks ]
- Mini-Mental State Examination (MMSE) [ Time Frame: 96 weeks ]A 30-point questionnaire that provides a quantitative measure of cognitive mental status in adults.
- 24-Item Alzheimer's Disease Cooperative Study/Activities of Daily Living Scale Adapted for Patients with Mild Cognitive Impairment (ADCS-MCI-ADL-24) [ Time Frame: 96 weeks ]A 24-item, study partner-based assessment of activities of daily living designed specifically for AD patients.
- Functional Activities Questionnaire (FAQ) [ Time Frame: 96 weeks ]A questionnaire used to measure level of assistance (functional disability) needed for carrying out instrumental activities in daily living.
- Repeatable Battery for Assessment of Neuropsychological Status (RBANS) [ Time Frame: 96 weeks ]A standardized neurocognitive battery that measures cognitive decline or improvement across five neurocognitive domains.
- Alzheimer's Disease Cooperative Study Clinical Global Impression of Change for Mild Cognitive Impairment (ADCS-CGIC-MCI). [ Time Frame: 96 weeks ]The instrument assesses the physician's global impression of change four major cognitive domains.
- Alzheimer's Disease Assessment Scale (14-Item) Cognition Portion (ADAS-Cog-14) [ Time Frame: 96 weeks ]A scale that assesses the cognitive impairments most common in AD.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 55 Years to 85 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02880956
Contact: ABBVIE CALL CENTER | 847.283.8955 | abbvieclinicaltrials@abbvie.com |

Study Director: | AbbVie Inc. | AbbVie |
Responsible Party: | AbbVie |
ClinicalTrials.gov Identifier: | NCT02880956 History of Changes |
Other Study ID Numbers: |
M15-566 2016-001634-10 ( EudraCT Number ) |
First Posted: | August 26, 2016 Key Record Dates |
Last Update Posted: | March 9, 2018 |
Last Verified: | March 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | Yes | |
Studies a U.S. FDA-regulated Device Product: | No | |
Product Manufactured in and Exported from the U.S.: | No |
Keywords provided by AbbVie:
Early Alzheimer's Disease Mild Cognitive Impairment (MCI) Mild Alzheimer's Disease (AD) Tau Early dementia |
Tauopathies AD Neurodegenerative diseases Memory loss Nervous system diseases |
Additional relevant MeSH terms:
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders |