Efficacy and Safety Study of ABT-384 in Subjects With Mild-to-Moderate Alzheimer's Disease
- Registration Number
- NCT01137526
- Lead Sponsor
- AbbVie (prior sponsor, Abbott)
- 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 treatment groups (ABT-384, donepezil, or placebo) for a 12-week Treatment Period.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 267
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ABT-384 Dose 2 ABT-384 - placebo placebo - donepezil donepezil - ABT-384 Dose 1 ABT-384 -
- Primary Outcome Measures
Name Time Method Change from baseline to final observation in the Alzheimer's Disease Assessment Scale-Cognition portion (ADAS-cog) total score 12 Weeks
- Secondary Outcome Measures
Name Time Method Mini Mental Status Examination (MMSE) score at Baseline, Weeks 4, 8, and 12 12 Weeks Clinician's Interview Based Impression of Change-plus (CIBIC-plus) score at Baseline, Weeks 4, 8, and 12 12 Weeks Neuropsychiatric Inventory (NPI) score at Baseline, Weeks 4, 8, and 12 12 Weeks Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) score at Baseline, Weeks 4, 8, and 12 12 Weeks
Trial Locations
- Locations (30)
Site Reference ID/Investigator# 45584
🇿🇦Belville, South Africa
Site Reference ID/Investigator# 37944
🇷🇺Moscow, Russian Federation
Site Reference ID/Investigator# 36327
🇬🇧Bath, United Kingdom
Site Reference ID/Investigator# 36304
🇷🇺Kazan, Russian Federation
Site Reference ID/Investigator# 35902
🇬🇧Northampton, United Kingdom
Site Reference ID/Investigator# 45583
🇿🇦Johannesburg, South Africa
Site Reference ID/Investigator# 36306
🇷🇺Kirov, Russian Federation
Site Reference ID/Investigator# 26904
🇷🇺St. Petersburg, Russian Federation
Site Reference ID/Investigator# 35657
🇬🇧Blackburn, United Kingdom
Site Reference ID/Investigator# 47102
🇿🇦George, South Africa
Site Reference ID/Investigator# 39855
🇺🇦Donetsk, Ukraine
Site Reference ID/Investigator# 36330
🇬🇧Crowborough, United Kingdom
Site Reference ID/Investigator# 44123
🇬🇧Ivybridge, Devon, United Kingdom
Site Reference ID/Investigator# 36328
🇬🇧Oxford, United Kingdom
Site Reference ID/Investigator# 35658
🇬🇧London, United Kingdom
Site Reference ID/Investigator# 27002
🇺🇦Poltava, Ukraine
Site Reference ID/Investigator# 40834
🇷🇺Ekaterinburg, Russian Federation
Site Reference ID/Investigator# 26912
🇺🇦Kiev, Ukraine
Site Reference ID/Investigator# 36329
🇬🇧Peterborough, United Kingdom
Site Reference ID/Investigator# 35660
🇺🇦Vinnytsia, Ukraine
Site Reference ID/Investigator# 40484
🇺🇦Lviv, Ukraine
Site Reference ID/Investigator# 36326
🇬🇧Glasgow, United Kingdom
Site Reference ID/Investigator# 26909
🇷🇺Saratov, Russian Federation
Site Reference ID/Investigator# 26902
🇷🇺St. Petersburg, Russian Federation
Site Reference ID/Investigator# 36305
🇷🇺St. Petersburg, Russian Federation
Site Reference ID/Investigator# 40482
🇺🇦Simferopil, Ukraine
Site Reference ID/Investigator# 26914
🇺🇦Kharkiv, Ukraine
Site Reference ID/Investigator# 39856
🇺🇦Poltava, Ukraine
Site Reference ID/Investigator# 40483
🇺🇦Ternopil, Ukraine
Site Reference ID/Investigator# 38383
🇷🇺Yaroslavl, Russian Federation