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

Completed · Phase 2 · Has a placebo group

Conditions studied: Alzheimer's Disease

In brief

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

Key facts

Study ID

NCT00948909

Run by

AbbVie (prior sponsor, Abbott)

People needed

274

Starts

2009-10-01

Expected to finish

2010-11-01

Last updated by the study team

2013-01-31

Who can join

Age: 55 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• 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# 22944 — Pleven, Bulgaria
• Site Reference ID/Investigator# 22942 — Plovdiv, Bulgaria
• Site Reference ID/Investigator# 22945 — Sofia, Bulgaria
• Site Reference ID/Investigator# 22946 — Sofia, Bulgaria
• Site Reference ID/Investigator# 20276 — Litoměřice, Czechia
• Site Reference ID/Investigator# 20273 — Pilsen, Czechia
• Site Reference ID/Investigator# 20274 — Prague, Czechia
• Site Reference ID/Investigator# 20272 — Prague, Czechia
• Site Reference ID/Investigator# 20701 — Prague, Czechia
• Site Reference ID/Investigator# 23625 — Bratislava, Slovakia
• Site Reference ID/Investigator# 23624 — Bratislava, Slovakia
• Site Reference ID/Investigator# 23622 — Michalovce, Slovakia
• Site Reference ID/Investigator# 23942 — Rimavská Sobota, Slovakia
• 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, South Africa
• Site Reference ID/Investigator# 20187 — Blackburn, United Kingdom
• Site Reference ID/Investigator# 20183 — Bradford, United Kingdom

Full record on ClinicalTrials.gov

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