Efficacy and Safety Study of ABT-384 in Subjects With Mild-to-Moderate Alzheimer's Disease
NCT ID: NCT01137526
Last Updated: 2013-01-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
267 participants
INTERVENTIONAL
2010-05-31
2011-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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ABT-384 Dose 1
ABT-384
Subjects will take study drug once daily for 12 weeks
ABT-384 Dose 2
ABT-384
Subjects will take study drug once daily for 12 weeks
donepezil
donepezil
Subjects will take study drug once daily for 12 weeks.
placebo
placebo
Subjects will take study drug once daily for 12 weeks
Interventions
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ABT-384
Subjects will take study drug once daily for 12 weeks
donepezil
Subjects will take study drug once daily for 12 weeks.
placebo
Subjects will take study drug once daily for 12 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Subject is male or female between the ages of 55 and 90 years of age, inclusive, at Day-1.
3. Subject meets the NINCDS/ADRDA criteria for probable AD.
4. Subject has a Mini-Mental Status Examination (MMSE) score of 10 to 24, inclusive, at Screening Visit 1.
5. Subject has a Cornell Scale for Depression in Dementia (CSDD) score ≤ 10 at Screening Visit 1.
6. 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.
7. If female, subject must be postmenopausal for at least 2 years or surgically sterile.
8. If male, the subject is surgically sterile (vasectomy), is sexually inactive, or is using a barrier method of birth control.
9. 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.
10. 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 Criteria
2. 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.
3. 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.
4. 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.
5. 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.
6. For any reason the investigator considers the subject to be an unsuitable candidate to receive ABT-384 or donepezil.
55 Years
90 Years
ALL
No
Sponsors
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AbbVie (prior sponsor, Abbott)
INDUSTRY
Responsible Party
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Principal Investigators
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Gerard Marek, MD
Role: STUDY_DIRECTOR
AbbVie
Locations
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Site Reference ID/Investigator# 36304
Kazan', , Russia
Site Reference ID/Investigator# 36306
Kirov, , Russia
Site Reference ID/Investigator# 37944
Moscow, , Russia
Site Reference ID/Investigator# 26904
Saint Petersburg, , Russia
Site Reference ID/Investigator# 26902
Saint Petersburg, , Russia
Site Reference ID/Investigator# 36305
Saint Petersburg, , Russia
Site Reference ID/Investigator# 26909
Saratov, , Russia
Site Reference ID/Investigator# 38383
Yaroslavl, , Russia
Site Reference ID/Investigator# 40834
Yekaterinburg, , Russia
Site Reference ID/Investigator# 45584
Belville, , South Africa
Site Reference ID/Investigator# 47102
George, , South Africa
Site Reference ID/Investigator# 45583
Johannesburg, , South Africa
Site Reference ID/Investigator# 39855
Donetsk, , Ukraine
Site Reference ID/Investigator# 26914
Kharkiv, , Ukraine
Site Reference ID/Investigator# 26912
Kiev, , Ukraine
Site Reference ID/Investigator# 40484
Lviv, , Ukraine
Site Reference ID/Investigator# 27002
Poltava, , Ukraine
Site Reference ID/Investigator# 39856
Poltava, , Ukraine
Site Reference ID/Investigator# 40482
Simferopil, , Ukraine
Site Reference ID/Investigator# 40483
Ternopil, , Ukraine
Site Reference ID/Investigator# 35660
Vinnytsia, , Ukraine
Site Reference ID/Investigator# 36327
Bath, , United Kingdom
Site Reference ID/Investigator# 35657
Blackburn, , United Kingdom
Site Reference ID/Investigator# 36330
Crowborough, , United Kingdom
Site Reference ID/Investigator# 36326
Glasgow, , United Kingdom
Site Reference ID/Investigator# 44123
Ivybridge, Devon, , United Kingdom
Site Reference ID/Investigator# 35658
London, , United Kingdom
Site Reference ID/Investigator# 35902
Northampton, , United Kingdom
Site Reference ID/Investigator# 36328
Oxford, , United Kingdom
Site Reference ID/Investigator# 36329
Peterborough, , United Kingdom
Countries
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References
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Marek GJ, Katz DA, Meier A, Greco N 4th, Zhang W, Liu W, Lenz RA. Efficacy and safety evaluation of HSD-1 inhibitor ABT-384 in Alzheimer's disease. Alzheimers Dement. 2014 Oct;10(5 Suppl):S364-73. doi: 10.1016/j.jalz.2013.09.010. Epub 2014 Jan 10.
Other Identifiers
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2009 017801-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M12-033
Identifier Type: -
Identifier Source: org_study_id
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