search
Back to results

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

Primary Purpose

Alzheimer's Disease

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ABT-288
donepezil
placebo
Sponsored by
AbbVie (prior sponsor, Abbott)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease

Eligibility Criteria

55 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers
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.

Sites / Locations

  • Site Reference ID/Investigator# 22687
  • Site Reference ID/Investigator# 22636
  • Site Reference ID/Investigator# 23702
  • Site Reference ID/Investigator# 22689
  • Site Reference ID/Investigator# 22635
  • Site Reference ID/Investigator# 22633
  • Site Reference ID/Investigator# 22637
  • Site Reference ID/Investigator# 22632
  • Site Reference ID/Investigator# 22634
  • Site Reference ID/Investigator# 24563
  • Site Reference ID/Investigator# 22630
  • Site Reference ID/Investigator# 22625
  • Site Reference ID/Investigator# 22624
  • Site Reference ID/Investigator# 22629
  • Site Reference ID/Investigator# 24565
  • Site Reference ID/Investigator# 24566
  • Site Reference ID/Investigator# 22622
  • Site Reference ID/Investigator# 22623
  • Site Reference ID/Investigator# 22628
  • Site Reference ID/Investigator# 43143
  • Site Reference ID/Investigator# 22627

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Placebo Comparator

Arm Label

Arm 1, Dose 1, ABT-288

Arm 2, Dose 2, ABT-288

donepezil

sugar pill

Arm Description

Low Dose

High dose

Outcomes

Primary Outcome Measures

ADAS-cog: Alzheimer's Disease Assessment Scale - Cognition portion

Secondary Outcome Measures

MMSE: Mini Mental Status Exam
NPI: Neuropsychiatric Inventory
ADCS-ADL: Alzheimer's Disease Cooperative Study
CIBIC-Plus: Clinician Interview-Baed Impression of Change - plus

Full Information

First Posted
November 20, 2009
Last Updated
June 1, 2018
Sponsor
AbbVie (prior sponsor, Abbott)
search

1. Study Identification

Unique Protocol Identification Number
NCT01018875
Brief Title
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

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
February 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie (prior sponsor, Abbott)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
242 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1, Dose 1, ABT-288
Arm Type
Experimental
Arm Description
Low Dose
Arm Title
Arm 2, Dose 2, ABT-288
Arm Type
Experimental
Arm Description
High dose
Arm Title
donepezil
Arm Type
Active Comparator
Arm Title
sugar pill
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
ABT-288
Intervention Description
Subjects will take 4 capsules once daily for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
donepezil
Other Intervention Name(s)
Aricept
Intervention Description
Subjects will take 4 capsules once daily for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Subjects will take 4 capsules once daily for 12 weeks.
Primary Outcome Measure Information:
Title
ADAS-cog: Alzheimer's Disease Assessment Scale - Cognition portion
Time Frame
Screening Visit 1 & 2, Day -1, Weeks 4, 8 & 12/PD
Secondary Outcome Measure Information:
Title
MMSE: Mini Mental Status Exam
Time Frame
Screening Visit 1 & 2, Day -1, Weeks 4, 8 & 12/PD
Title
NPI: Neuropsychiatric Inventory
Time Frame
Day -1, Weeks 4,8, 12/PD
Title
ADCS-ADL: Alzheimer's Disease Cooperative Study
Time Frame
Day -1, Weeks 4,8 & 12/PD
Title
CIBIC-Plus: Clinician Interview-Baed Impression of Change - plus
Time Frame
Day -1, Weeks 4,8 & 12/PD]

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George Haig
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Site Reference ID/Investigator# 22687
City
Kazan
ZIP/Postal Code
420012
Country
Russian Federation
Facility Name
Site Reference ID/Investigator# 22636
City
Moscow
ZIP/Postal Code
115522
Country
Russian Federation
Facility Name
Site Reference ID/Investigator# 23702
City
Moscow
ZIP/Postal Code
123995
Country
Russian Federation
Facility Name
Site Reference ID/Investigator# 22689
City
Saratov
ZIP/Postal Code
410060
Country
Russian Federation
Facility Name
Site Reference ID/Investigator# 22635
City
St. Petersburg
ZIP/Postal Code
190005
Country
Russian Federation
Facility Name
Site Reference ID/Investigator# 22633
City
St. Petersburg
ZIP/Postal Code
190103
Country
Russian Federation
Facility Name
Site Reference ID/Investigator# 22637
City
St. Petersburg
ZIP/Postal Code
190121
Country
Russian Federation
Facility Name
Site Reference ID/Investigator# 22632
City
St. Petersburg
ZIP/Postal Code
192019
Country
Russian Federation
Facility Name
Site Reference ID/Investigator# 22634
City
St. Petersburg
ZIP/Postal Code
192019
Country
Russian Federation
Facility Name
Site Reference ID/Investigator# 24563
City
St. Petersburg
ZIP/Postal Code
194044
Country
Russian Federation
Facility Name
Site Reference ID/Investigator# 22630
City
Dnipropetrovs'k
ZIP/Postal Code
49027
Country
Ukraine
Facility Name
Site Reference ID/Investigator# 22625
City
Donetsk
Country
Ukraine
Facility Name
Site Reference ID/Investigator# 22624
City
Glevakha
ZIP/Postal Code
08631
Country
Ukraine
Facility Name
Site Reference ID/Investigator# 22629
City
Kharkiv
ZIP/Postal Code
61168
Country
Ukraine
Facility Name
Site Reference ID/Investigator# 24565
City
Kherson
ZIP/Postal Code
73488
Country
Ukraine
Facility Name
Site Reference ID/Investigator# 24566
City
Kiev
ZIP/Postal Code
04112
Country
Ukraine
Facility Name
Site Reference ID/Investigator# 22622
City
Kiev
ZIP/Postal Code
04114
Country
Ukraine
Facility Name
Site Reference ID/Investigator# 22623
City
Kiev
ZIP/Postal Code
05113
Country
Ukraine
Facility Name
Site Reference ID/Investigator# 22628
City
Lugansk
ZIP/Postal Code
91045
Country
Ukraine
Facility Name
Site Reference ID/Investigator# 43143
City
Odessa
ZIP/Postal Code
65006
Country
Ukraine
Facility Name
Site Reference ID/Investigator# 22627
City
Poltava
ZIP/Postal Code
36006
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
28720101
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs