Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

COMPLETED

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

Lead Sponsor:

AbbVie (prior sponsor, Abbott)

Conditions:

Alzheimer's Disease

Eligibility:

All Genders

55-90 years

Phase:

PHASE2

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 fo...

Eligibility Criteria

Inclusion

  • 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

  • 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).

Key Trial Info

Start Date :

October 1 2009

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

November 1 2010

Estimated Enrollment :

274 Patients enrolled

Trial Details

Trial ID

NCT00948909

Start Date

October 1 2009

End Date

November 1 2010

Last Update

January 31 2013

Active Locations (29)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 8 (29 locations)

1

Site Reference ID/Investigator# 19904

Fresno, California, United States, 93720

2

Site Reference ID/Investigator# 23025

West Palm Beach, Florida, United States, 33407

3

Site Reference ID/Investigator# 19905

Indianapolis, Indiana, United States, 46260

4

Site Reference ID/Investigator# 22944

Pleven, Bulgaria, 5800