Efficacy and Safety Study for Subjects With Mild-to-Moderate Alzheimer's Disease

Phase 2

Completed

• Conditions: Alzheimer's Disease
• Interventions: Drug: Placebo; Drug: ABT-126; Drug: donepezil

• Registration Number: NCT00948909
• Lead Sponsor: AbbVie (prior sponsor, Abbott)

Brief Summary

This is a efficacy and safety study evaluating new treatment for subjects with mild to moderate Alzheimer's Disease.

Detailed Description

This is a Phase 2 study designed to evaluate the efficacy and safety of ABT-126 in approximately 260 adults with mild-to-moderate Alzheimer's disease (AD). Subjects will be randomized to one of the four treatment groups (ABT-126, donepezil, or placebo) for a 12-week Treatment Period. Acronyms are listed in the secondary outcome section, below, you will find a list of the acronyms defined:

* MMSE - Mini Mental Status Exam

* QoL-AD - Quality of Life - Alzheimer's Disease

* CIBIC-plus - Clinician Interview-Based Impression of Change

* NPI - Neuropsychiatric Inventory

* CSDD - The Cornell Scale for depression in Dementia

* ADCS-ADL - Alzheimer's Disease Cooperative Study - Activities of Daily Living

Study Timeline

• Study First Submitted: 2009-07-24
• Study First Submitted QC: 2009-07-28
• Study First Posted: 2009-07-29
• Study Start: 2009-10
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Disposition First Submitted: 2011-11-22
• Disposition First Submitted QC: 2011-11-22
• Disposition First Posted: 2011-11-24
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-29
• Last Update Posted: 2013-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 274

Inclusion Criteria

• The subject is a male or female between the ages of 55 and 90 years, inclusive, at Screening Visit 1.
• The subject meets the NINCDS/ADRDA criteria for probable AD.
• The subject has a Mini-Mental Status Examination (MMSE) total score of 10 to 24, inclusive, at Screening Visit 1.
• The subject has a Modified Hachinski Ischemic Scale (MHIS) score of less than or equal to 4 at Screening Visit 1.
• If female, subject must be postmenopausal for at least two years or surgically sterile
• The subject has an identified, reliable, caregiver.

Exclusion Criteria

• The subject is currently taking or has taken a medication for the treatment of Alzheimer's disease or dementia within 60 days prior to Screening Visit 1
• The subject has a history of any significant neurologic disease other than AD.
• In the opinion of the investigator, the subject has any clinically significant uncontrolled medical or psychiatric illness.
• The subject has reported history of discontinuation of donepezil due to lack of efficacy.
• The subject has a history of intolerance or adverse reaction to donepezil that led to discontinuation.
• The subject has a known hypersensitivity to donepezil, piperidine derivatives, or any of the excipients in either donepezil hydrochloride or ABT-126 formulations.
• Patient uses non-prescribed drugs of abuse or has a history of drug or alcohol abuse/dependence.
• Subjects with AST and ALT values at Screening Visit 1 that are greater than or equal to 1.5-fold the upper limit of normal (ULN).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A. Sugar Pill	Placebo	-
B. ABT-126	ABT-126	-
C. ABT-126	ABT-126	-
D. donepezil	donepezil	-

Primary Outcome Measures

Name	Time	Method
ADAS-Cog - Alzheimer's Disease Assessment Scale Cognition portion	Measurements up through 12 weeks.

Secondary Outcome Measures

Name	Time	Method
MMSE, QoL-AD, CIBIC-plus, NPI, CSDD, ADAS-Cog (13 item) and ADCS-ADL. Note: Acronyms are fully defined in the area titled Detailed Description.	Measurements up through 12 weeks.

Trial Locations

Locations (29)

Site Reference ID/Investigator# 22946; 🇧🇬 Sofia, Bulgaria

Site Reference ID/Investigator# 20263; 🇿🇦 Richards Bay, South Africa

Site Reference ID/Investigator# 20183; 🇬🇧 Bradford, United Kingdom

Site Reference ID/Investigator# 20701; 🇨🇿 Prague 5, Czech Republic

Site Reference ID/Investigator# 20184; 🇬🇧 Glasgow, United Kingdom

Site Reference ID/Investigator# 22942; 🇧🇬 Plovdiv, Bulgaria

Site Reference ID/Investigator# 20266; 🇿🇦 Cape Town, South Africa

Site Reference ID/Investigator# 20261; 🇿🇦 Durban, South Africa

Site Reference ID/Investigator# 22944; 🇧🇬 Pleven, Bulgaria

Site Reference ID/Investigator# 22945; 🇧🇬 Sofia, Bulgaria

Site Reference ID/Investigator# 20190; 🇬🇧 London, United Kingdom

Site Reference ID/Investigator# 20191; 🇬🇧 Crowborough, United Kingdom

Site Reference ID/Investigator# 20267; 🇿🇦 Belville, South Africa

Site Reference ID/Investigator# 20187; 🇬🇧 Blackburn, United Kingdom

Site Reference ID/Investigator# 23942; 🇸🇰 Rimavska Sobota, Slovakia

Site Reference ID/Investigator# 20265; 🇿🇦 Johannesburg, South Africa

Site Reference ID/Investigator# 20271; 🇿🇦 Port Elizabeth, South Africa

Site Reference ID/Investigator# 20192; 🇬🇧 Southampton, United Kingdom

Site Reference ID/Investigator# 21682; 🇿🇦 George, South Africa

Site Reference ID/Investigator# 19904; 🇺🇸 Fresno, California, United States

Site Reference ID/Investigator# 23025; 🇺🇸 West Palm Beach, Florida, United States

Site Reference ID/Investigator# 19905; 🇺🇸 Indianapolis, Indiana, United States

Site Reference ID/Investigator# 20274; 🇨🇿 Prague 10, Czech Republic

Site Reference ID/Investigator# 20272; 🇨🇿 Prague 2, Czech Republic

Site Reference ID/Investigator# 23624; 🇸🇰 Bratislava, Slovakia

Site Reference ID/Investigator# 20273; 🇨🇿 Plzen, Czech Republic

Site Reference ID/Investigator# 20276; 🇨🇿 Litomerice, Czech Republic

Site Reference ID/Investigator# 23622; 🇸🇰 Michalovce, Slovakia

Site Reference ID/Investigator# 23625; 🇸🇰 Bratislava, Slovakia