NCT01018875

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
242

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2009

Shorter than P25 for phase_2

Geographic Reach
2 countries

21 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 20, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 24, 2009

Completed
7 days until next milestone

Study Start

First participant enrolled

December 1, 2009

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

June 6, 2018

Status Verified

January 1, 2013

Enrollment Period

1.2 years

First QC Date

November 20, 2009

Last Update Submit

June 1, 2018

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

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

    Screening Visit 1 & 2, Day -1, Weeks 4, 8 & 12/PD

Secondary Outcomes (4)

  • MMSE: Mini Mental Status Exam

    Screening Visit 1 & 2, Day -1, Weeks 4, 8 & 12/PD

  • NPI: Neuropsychiatric Inventory

    Day -1, Weeks 4,8, 12/PD

  • ADCS-ADL: Alzheimer's Disease Cooperative Study

    Day -1, Weeks 4,8 & 12/PD

  • CIBIC-Plus: Clinician Interview-Baed Impression of Change - plus

    Day -1, Weeks 4,8 & 12/PD]

Study Arms (4)

Arm 1, Dose 1, ABT-288

EXPERIMENTAL

Low Dose

Drug: ABT-288

Arm 2, Dose 2, ABT-288

EXPERIMENTAL

High dose

Drug: ABT-288

donepezil

ACTIVE COMPARATOR
Drug: donepezil

sugar pill

PLACEBO COMPARATOR
Drug: placebo

Interventions

ABT-288DRUG

Subjects will take 4 capsules once daily for 12 weeks.

Arm 1, Dose 1, ABT-288Arm 2, Dose 2, ABT-288
donepezilDRUG

Subjects will take 4 capsules once daily for 12 weeks.

Also known as: Aricept
donepezil
placeboDRUG

Subjects will take 4 capsules once daily for 12 weeks.

sugar pill

Eligibility Criteria

Age55 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

Site Reference ID/Investigator# 22687

Kazan', 420012, Russia

Location

Site Reference ID/Investigator# 22636

Moscow, 115522, Russia

Location

Site Reference ID/Investigator# 23702

Moscow, 123995, Russia

Location

Site Reference ID/Investigator# 22635

Saint Petersburg, 190005, Russia

Location

Site Reference ID/Investigator# 22633

Saint Petersburg, 190103, Russia

Location

Site Reference ID/Investigator# 22637

Saint Petersburg, 190121, Russia

Location

Site Reference ID/Investigator# 22632

Saint Petersburg, 192019, Russia

Location

Site Reference ID/Investigator# 22634

Saint Petersburg, 192019, Russia

Location

Site Reference ID/Investigator# 24563

Saint Petersburg, 194044, Russia

Location

Site Reference ID/Investigator# 22689

Saratov, 410060, Russia

Location

Site Reference ID/Investigator# 22630

Dnipro, 49027, Ukraine

Location

Site Reference ID/Investigator# 22625

Donetsk, Ukraine

Location

Site Reference ID/Investigator# 22624

Hlevakha, 08631, Ukraine

Location

Site Reference ID/Investigator# 22629

Kharkiv, 61168, Ukraine

Location

Site Reference ID/Investigator# 24565

Kherson, 73488, Ukraine

Location

Site Reference ID/Investigator# 24566

Kiev, 04112, Ukraine

Location

Site Reference ID/Investigator# 22622

Kiev, 04114, Ukraine

Location

Site Reference ID/Investigator# 22623

Kiev, 05113, Ukraine

Location

Site Reference ID/Investigator# 22628

Luhansk, 91045, Ukraine

Location

Site Reference ID/Investigator# 43143

Odesa, 65006, Ukraine

Location

Site Reference ID/Investigator# 22627

Poltava, 36006, Ukraine

Location

Related 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.

    PMID: 28720101BACKGROUND

MeSH Terms

Conditions

Alzheimer Disease

Interventions

2-(4'-(5-methylhexahydropyrrolo(3,4-b)pyrrol-1-yl)biphenyl-4-yl)-2H-pyridazin-3-oneDonepezil

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

IndansIndenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPolycyclic Compounds

Study Officials

  • George Haig

    AbbVie

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2009

First Posted

November 24, 2009

Study Start

December 1, 2009

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

June 6, 2018

Record last verified: 2013-01

Locations

UA(11)RU(10)