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

Study Description

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Brief Summary:

This study seeks to evaluate the efficacy and safety of ABBV-8E12 in subjects with Early Alzheimer's Disease.

Condition or disease	Intervention/treatment	Phase
Alzheimer's Disease	Drug: ABBV-8E12; Drug: placebo for ABBV-8E12	Phase 2

Study Design

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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

Arms and Interventions

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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

Outcome Measures

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Primary Outcome Measures :

1. Adverse Events [ Time Frame: 112 weeks ]
2. Clinical Dementia Rating - Sum of Boxes (CDR-SB) [ Time Frame: Week 96 ]
   A scale used to quantify the severity of symptoms of dementia.

Secondary Outcome Measures :

1. 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).
2. Serum concentration at the end of a dose interval (Ctrough) for ABBV-8E12 [ Time Frame: 96 weeks ]
3. Area under the concentration time curve (AUC) for ABBV-8E12 [ Time Frame: 16 weeks ]
4. Time to Cmax (Tmax) for ABBV-8E12 [ Time Frame: 16 weeks ]
5. Maximum observed serum concentration (Cmax) for ABBV-8E12 [ Time Frame: 16 weeks ]
6. Mini-Mental State Examination (MMSE) [ Time Frame: 96 weeks ]
   A 30-point questionnaire that provides a quantitative measure of cognitive mental status in adults.
7. 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.
8. 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.
9. 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.
10. 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.
11. 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.

Eligibility Criteria

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Ages Eligible for Study:	55 Years to 85 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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:

• 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.

Contacts and Locations

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Contacts

Contact: ABBVIE CALL CENTER	847.283.8955	abbvieclinicaltrials@abbvie.com

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Sponsors and Collaborators

AbbVie

Investigators

Study Director:	AbbVie Inc.	AbbVie

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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