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

Alzheimer's Disease Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of ABT-126 in Subjects With Mild-to-Moderate Alzheimer's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00948909
• Other study ID #: M10-984
• Secondary ID: 2009-011424-64
• Status: Completed
• Phase: Phase 2
• First received: July 24, 2009
• Last updated: January 29, 2013
• Start date: October 2009
• Est. completion date: November 2010

Study information

• Verified date: January 2013
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 274
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years to 90 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• Placebo
Placebo intervention
• ABT-126
Experimental intervention
• donepezil
Active comparator intervention

Locations

Country	Name	City	State
Bulgaria	Site Reference ID/Investigator# 22944	Pleven
Bulgaria	Site Reference ID/Investigator# 22942	Plovdiv
Bulgaria	Site Reference ID/Investigator# 22945	Sofia
Bulgaria	Site Reference ID/Investigator# 22946	Sofia
Czech Republic	Site Reference ID/Investigator# 20276	Litomerice
Czech Republic	Site Reference ID/Investigator# 20273	Plzen
Czech Republic	Site Reference ID/Investigator# 20274	Prague 10
Czech Republic	Site Reference ID/Investigator# 20272	Prague 2
Czech Republic	Site Reference ID/Investigator# 20701	Prague 5
Slovakia	Site Reference ID/Investigator# 23624	Bratislava
Slovakia	Site Reference ID/Investigator# 23625	Bratislava
Slovakia	Site Reference ID/Investigator# 23622	Michalovce
Slovakia	Site Reference ID/Investigator# 23942	Rimavska Sobota
South Africa	Site Reference ID/Investigator# 20267	Belville
South Africa	Site Reference ID/Investigator# 20266	Cape Town
South Africa	Site Reference ID/Investigator# 20261	Durban
South Africa	Site Reference ID/Investigator# 21682	George
South Africa	Site Reference ID/Investigator# 20265	Johannesburg
South Africa	Site Reference ID/Investigator# 20271	Port Elizabeth
South Africa	Site Reference ID/Investigator# 20263	Richards Bay
United Kingdom	Site Reference ID/Investigator# 20187	Blackburn
United Kingdom	Site Reference ID/Investigator# 20183	Bradford
United Kingdom	Site Reference ID/Investigator# 20191	Crowborough
United Kingdom	Site Reference ID/Investigator# 20184	Glasgow
United Kingdom	Site Reference ID/Investigator# 20190	London
United Kingdom	Site Reference ID/Investigator# 20192	Southampton
United States	Site Reference ID/Investigator# 19904	Fresno	California
United States	Site Reference ID/Investigator# 19905	Indianapolis	Indiana
United States	Site Reference ID/Investigator# 23025	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie (prior sponsor, Abbott)

Countries where clinical trial is conducted

United States,  Bulgaria,  Czech Republic,  Slovakia,  South Africa,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ADAS-Cog - Alzheimer's Disease Assessment Scale Cognition portion		Measurements up through 12 weeks.	No
Secondary	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.	No