Clinical trial NCT01018875: Efficacy and Safety Study of ABT-288 in Subjects With Mild-to-Moderate Alzheimer's Disease
Official title: A Randomized, Double-Blind, Active- and Placebo-Controlled Study to Evaluate the Efficacy and Safety of ABT-288 in Subjects With Mild-to-Moderate Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer's Disease
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2009-11-24
Enrollment: 242
Sex: ALL
Minimum age (years): 55
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Efficacy and safety study of ABT-288 in adults with mild-to-moderate Alzheimer's disease.


Eligibility criteria: Inclusion Criteria: 1. Have voluntarily signed an informed consent. 2. Subject meets diagnostic criteria criteria for probable AD (Alzheimer's Disease). 3. Female subjects must be postmenopausal for at least 2 years or surgically sterile. 4. Male subjects must be surgically sterile, sexually inactive or using a barrier method of birth control. 5. Subject has an identified, reliable caregiver. 6. Subject has a CT or MRI scan within 36 months prior to randomization. 7. 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 ECG Exclusion Criteria: 1. Subject is currently taking or has taken a medication for the treatment of AD or dementia with 60 days of Screening visit, or is participating in cognitive therapy for the treatment of AD or dementia. 2. Subject uses non-prescribed drugs of abuse or has a history of drug or alcohol abuse/dependence. 3. Subject has a history of any significant neurologic disease other than AD. 4. Subject has a history of intolerance or adverse reaction to donepezil that led to discontinuation. 5. Subject has received any investigation product within 6 weeks prior to study drug administration.

Primary outcomes:
measure: ADAS-cog: Alzheimer's Disease Assessment Scale - Cognition portion
timeFrame: Screening Visit 1 & 2, Day -1, Weeks 4, 8 & 12/PD
Secondary outcomes:
measure: MMSE: Mini Mental Status Exam
timeFrame: Screening Visit 1 & 2, Day -1, Weeks 4, 8 & 12/PD
measure: NPI: Neuropsychiatric Inventory
timeFrame: Day -1, Weeks 4,8, 12/PD
measure: ADCS-ADL: Alzheimer's Disease Cooperative Study
timeFrame: Day -1, Weeks 4,8 & 12/PD
measure: CIBIC-Plus: Clinician Interview-Baed Impression of Change - plus
timeFrame: Day -1, Weeks 4,8 & 12/PD]
Other outcomes:
Locations:
city: Kazan
country: Russian Federation
facility: Site Reference ID/Investigator# 22687
city: Moscow
country: Russian Federation
facility: Site Reference ID/Investigator# 22636
city: Moscow
country: Russian Federation
facility: Site Reference ID/Investigator# 23702
city: Saratov
country: Russian Federation
facility: Site Reference ID/Investigator# 22689
city: St. Petersburg
country: Russian Federation
facility: Site Reference ID/Investigator# 22635
city: St. Petersburg
country: Russian Federation
facility: Site Reference ID/Investigator# 22633
city: St. Petersburg
country: Russian Federation
facility: Site Reference ID/Investigator# 22637
city: St. Petersburg
country: Russian Federation
facility: Site Reference ID/Investigator# 22632
city: St. Petersburg
country: Russian Federation
facility: Site Reference ID/Investigator# 22634
city: St. Petersburg
country: Russian Federation
facility: Site Reference ID/Investigator# 24563
city: Dnipropetrovs'k
country: Ukraine
facility: Site Reference ID/Investigator# 22630
city: Donetsk
country: Ukraine
facility: Site Reference ID/Investigator# 22625
city: Glevakha
country: Ukraine
facility: Site Reference ID/Investigator# 22624
city: Kharkiv
country: Ukraine
facility: Site Reference ID/Investigator# 22629
city: Kherson
country: Ukraine
facility: Site Reference ID/Investigator# 24565
city: Kiev
country: Ukraine
facility: Site Reference ID/Investigator# 24566
city: Kiev
country: Ukraine
facility: Site Reference ID/Investigator# 22622
city: Kiev
country: Ukraine
facility: Site Reference ID/Investigator# 22623
city: Lugansk
country: Ukraine
facility: Site Reference ID/Investigator# 22628
city: Odessa
country: Ukraine
facility: Site Reference ID/Investigator# 43143
city: Poltava
country: Ukraine
facility: Site Reference ID/Investigator# 22627
Study officials:
affiliation: AbbVie
name: George Haig
role: STUDY_DIRECTOR
References:
citation: Hung SY, Fu WM. Drug candidates in clinical trials for Alzheimer's disease. J Biomed Sci. 2017 Jul 19;24(1):47. doi: 10.1186/s12929-017-0355-7.