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 :	September 23, 2022

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Group 2; Dose 2 ABBV-8E12	Drug: ABBV-8E12; ABBV-8E12 solution for IV infusion
Experimental: Group 3; Dose 3 ABBV-8E12	Drug: ABBV-8E12; ABBV-8E12 solution for IV infusion
Experimental: Group 1; Dose 1 ABBV-8E12	Drug: ABBV-8E12; ABBV-8E12 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.
12. Neuropsychiatry Inventory (NPI) [ Time Frame: 96 weeks ]
    Assesses the presence of psychopathology in subjects with Alzheimer's disease and other dementias.

Eligibility Criteria

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Ages Eligible for Study:	55 Years to 85 Years (Adult, Older Adult)
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 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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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:	September 18, 2018
Last Verified:	September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes
Plan Description:	AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting Materials:	Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR); Analytic Code
Time Frame:	Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access Criteria:	Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
URL:	https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html

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 (AD); 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