Status:
COMPLETED
Efficacy and Safety Study of ABT-384 in 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
The purpose of this study is to test if the investigational medication, ABT-384, is a safe and effective treatment for adults with mild-to-moderate Alzheimer's Disease.
Detailed Description
This is a Phase 2 study designed to evaluate the safety and efficacy of ABT-384 in approximately 260 adults with mild-to-moderate Alzheimer's Disease (AD). Subjects will be randomized to one of four t...
Eligibility Criteria
Inclusion
- The subject and caregiver must voluntarily sign and date and informed consent. If the subject is not fully competent, full informed consent must be obtained from a legal representative and assent must be obtained from the subject.
- Subject is male or female between the ages of 55 and 90 years of age, inclusive, at Day-1.
- Subject meets the NINCDS/ADRDA criteria for probable AD.
- Subject has a Mini-Mental Status Examination (MMSE) score of 10 to 24, inclusive, at Screening Visit 1.
- Subject has a Cornell Scale for Depression in Dementia (CSDD) score ≤ 10 at Screening Visit 1.
- With the exception of a diagnosis of mild-to-moderate AD and the presence of stable medical conditions, the subject is generally in good health based on medical history, physical examination, vital signs, clinical lab tests and 12-lead ECG.
- If female, subject must be postmenopausal for at least 2 years or surgically sterile.
- If male, the subject is surgically sterile (vasectomy), is sexually inactive, or is using a barrier method of birth control.
- Subject has an identified reliable, caregiver (e.g., family member, social worker, nurse), who will provide support and ensure compliance with the study medication and procedures.
- Subject and caregiver are fluent in the language used for administration of the rating scales or cognitive tests and have sufficient visual, hearing and graphomotor skills to complete procedures.
Exclusion
- Subject has a known hypersensitivity or intolerance to donepezil that led to discontinuation or a known reported history of donepezil treatment failure.
- Subject is currently taking or has taken a medication for the treatment of AD or dementia within 60 days of Screening Visit 1, or is participating in cognitive therapy for the treatment of AD or dementia.
- Subject has a history of a drug or alcohol disorder (abuse/dependence), based on either DSM-IV-TR or ICD-10 criteria, excluding nicotine, within 2 years prior to Screening Visit 1.
- In the opinion of the investigator, the subject has any clinically significant uncontrolled medical or psychiatric illness that would affect the safety of the subject.
- The subject has a current thyroid disease or history of thyroid disease, and is not currently being treated with a stable dose of thyroid replacement medication.
- For any reason the investigator considers the subject to be an unsuitable candidate to receive ABT-384 or donepezil.
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
267 Patients enrolled
Trial Details
Trial ID
NCT01137526
Start Date
May 1 2010
End Date
July 1 2011
Last Update
January 29 2013
Active Locations (30)
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1
Site Reference ID/Investigator# 36304
Kazan', Russia, 420097
2
Site Reference ID/Investigator# 36306
Kirov, Russia, 610014
3
Site Reference ID/Investigator# 37944
Moscow, Russia, 119048
4
Site Reference ID/Investigator# 26904
Saint Petersburg, Russia, 190005