Efficacy and Safety Study of ABT-288 in Subjects With Mild-to-Moderate Alzheimer's Disease

Alzheimer's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01018875
• Other study ID #: M10-822
• Secondary ID: 2009-010704-29
• Status: Completed
• Phase: Phase 2
• Start date: December 2009
• Est. completion date: February 2011

Study information

• Verified date: January 2013
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 242
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• ABT-288
Subjects will take 4 capsules once daily for 12 weeks.
• donepezil
Subjects will take 4 capsules once daily for 12 weeks.
• placebo
Subjects will take 4 capsules once daily for 12 weeks.

Locations

Country	Name	City	State
Russian Federation	Site Reference ID/Investigator# 22687	Kazan
Russian Federation	Site Reference ID/Investigator# 22636	Moscow
Russian Federation	Site Reference ID/Investigator# 23702	Moscow
Russian Federation	Site Reference ID/Investigator# 22689	Saratov
Russian Federation	Site Reference ID/Investigator# 22632	St. Petersburg
Russian Federation	Site Reference ID/Investigator# 22633	St. Petersburg
Russian Federation	Site Reference ID/Investigator# 22634	St. Petersburg
Russian Federation	Site Reference ID/Investigator# 22635	St. Petersburg
Russian Federation	Site Reference ID/Investigator# 22637	St. Petersburg
Russian Federation	Site Reference ID/Investigator# 24563	St. Petersburg
Ukraine	Site Reference ID/Investigator# 22630	Dnipropetrovs'k
Ukraine	Site Reference ID/Investigator# 22625	Donetsk
Ukraine	Site Reference ID/Investigator# 22624	Glevakha
Ukraine	Site Reference ID/Investigator# 22629	Kharkiv
Ukraine	Site Reference ID/Investigator# 24565	Kherson
Ukraine	Site Reference ID/Investigator# 22622	Kiev
Ukraine	Site Reference ID/Investigator# 22623	Kiev
Ukraine	Site Reference ID/Investigator# 24566	Kiev
Ukraine	Site Reference ID/Investigator# 22628	Lugansk
Ukraine	Site Reference ID/Investigator# 43143	Odessa
Ukraine	Site Reference ID/Investigator# 22627	Poltava

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie (prior sponsor, Abbott)

Countries where clinical trial is conducted

Russian Federation,  Ukraine, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ADAS-cog: Alzheimer's Disease Assessment Scale - Cognition portion		Screening Visit 1 & 2, Day -1, Weeks 4, 8 & 12/PD
Secondary	MMSE: Mini Mental Status Exam		Screening Visit 1 & 2, Day -1, Weeks 4, 8 & 12/PD
Secondary	NPI: Neuropsychiatric Inventory		Day -1, Weeks 4,8, 12/PD
Secondary	ADCS-ADL: Alzheimer's Disease Cooperative Study		Day -1, Weeks 4,8 & 12/PD
Secondary	CIBIC-Plus: Clinician Interview-Baed Impression of Change - plus		Day -1, Weeks 4,8 & 12/PD]