NCT01137526

Brief Summary

The purpose of this study is to test if the investigational medication, ABT-384, is a safe and effective treatment for 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
267

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2010

Shorter than P25 for phase_2

Geographic Reach
4 countries

30 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

Study Start

First participant enrolled

May 1, 2010

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

May 7, 2010

Completed
28 days until next milestone

First Posted

Study publicly available on registry

June 4, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

January 29, 2013

Status Verified

January 1, 2013

Enrollment Period

1.2 years

First QC Date

May 7, 2010

Last Update Submit

January 24, 2013

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

  • Change from baseline to final observation in the Alzheimer's Disease Assessment Scale-Cognition portion (ADAS-cog) total score

    12 Weeks

Secondary Outcomes (4)

  • Mini Mental Status Examination (MMSE) score at Baseline, Weeks 4, 8, and 12

    12 Weeks

  • Clinician's Interview Based Impression of Change-plus (CIBIC-plus) score at Baseline, Weeks 4, 8, and 12

    12 Weeks

  • Neuropsychiatric Inventory (NPI) score at Baseline, Weeks 4, 8, and 12

    12 Weeks

  • Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) score at Baseline, Weeks 4, 8, and 12

    12 Weeks

Study Arms (4)

ABT-384 Dose 1

EXPERIMENTAL
Drug: ABT-384

ABT-384 Dose 2

EXPERIMENTAL
Drug: ABT-384

donepezil

ACTIVE COMPARATOR
Drug: donepezil

placebo

PLACEBO COMPARATOR
Drug: placebo

Interventions

ABT-384DRUG

Subjects will take study drug once daily for 12 weeks

ABT-384 Dose 1ABT-384 Dose 2
donepezilDRUG

Subjects will take study drug once daily for 12 weeks.

Also known as: Aricept
donepezil
placeboDRUG

Subjects will take study drug once daily for 12 weeks

placebo

Eligibility Criteria

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

You may qualify if:

  • The subject and caregiver must voluntarily sign and date and informed consent. If the subject is not fully competent, full informed consent must be obtained from a legal representative and assent must be obtained from the subject.
  • Subject is male or female between the ages of 55 and 90 years of age, inclusive, at Day-1.
  • Subject meets the NINCDS/ADRDA criteria for probable AD.
  • Subject has a Mini-Mental Status Examination (MMSE) score of 10 to 24, inclusive, at Screening Visit 1.
  • Subject has a Cornell Scale for Depression in Dementia (CSDD) score ≤ 10 at Screening Visit 1.
  • 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.
  • If female, subject must be postmenopausal for at least 2 years or surgically sterile.
  • If male, the subject is surgically sterile (vasectomy), is sexually inactive, or is using a barrier method of birth control.
  • 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.
  • 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.

You may not qualify if:

  • Subject has a known hypersensitivity or intolerance to donepezil that led to discontinuation or a known reported history of donepezil treatment failure.
  • 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.
  • 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.
  • 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.
  • 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.
  • For any reason the investigator considers the subject to be an unsuitable candidate to receive ABT-384 or donepezil.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (30)

Site Reference ID/Investigator# 36304

Kazan', 420097, Russia

Location

Site Reference ID/Investigator# 36306

Kirov, 610014, Russia

Location

Site Reference ID/Investigator# 37944

Moscow, 119048, Russia

Location

Site Reference ID/Investigator# 26904

Saint Petersburg, 190005, Russia

Location

Site Reference ID/Investigator# 26902

Saint Petersburg, 190103, Russia

Location

Site Reference ID/Investigator# 36305

Saint Petersburg, 198510, Russia

Location

Site Reference ID/Investigator# 26909

Saratov, 410060, Russia

Location

Site Reference ID/Investigator# 38383

Yaroslavl, 150030, Russia

Location

Site Reference ID/Investigator# 40834

Yekaterinburg, 620030, Russia

Location

Site Reference ID/Investigator# 45584

Belville, 7530, South Africa

Location

Site Reference ID/Investigator# 47102

George, 6529, South Africa

Location

Site Reference ID/Investigator# 45583

Johannesburg, 2196, South Africa

Location

Site Reference ID/Investigator# 39855

Donetsk, 83003, Ukraine

Location

Site Reference ID/Investigator# 26914

Kharkiv, 61177, Ukraine

Location

Site Reference ID/Investigator# 26912

Kiev, 04114, Ukraine

Location

Site Reference ID/Investigator# 40484

Lviv, 79010, Ukraine

Location

Site Reference ID/Investigator# 27002

Poltava, 36006, Ukraine

Location

Site Reference ID/Investigator# 39856

Poltava, 36024, Ukraine

Location

Site Reference ID/Investigator# 40482

Simferopil, 95006, Ukraine

Location

Site Reference ID/Investigator# 40483

Ternopil, 46020, Ukraine

Location

Site Reference ID/Investigator# 35660

Vinnytsia, 21005, Ukraine

Location

Site Reference ID/Investigator# 36327

Bath, BA1 3NG, United Kingdom

Location

Site Reference ID/Investigator# 35657

Blackburn, BB2 3HH, United Kingdom

Location

Site Reference ID/Investigator# 36330

Crowborough, TN6 1HB, United Kingdom

Location

Site Reference ID/Investigator# 36326

Glasgow, G20 0XA, United Kingdom

Location

Site Reference ID/Investigator# 44123

Ivybridge, Devon, PL21 9AB, United Kingdom

Location

Site Reference ID/Investigator# 35658

London, TW8 8DS, United Kingdom

Location

Site Reference ID/Investigator# 35902

Northampton, NN5 6UD, United Kingdom

Location

Site Reference ID/Investigator# 36328

Oxford, OX3 9DU, United Kingdom

Location

Site Reference ID/Investigator# 36329

Peterborough, PE2 7JU, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 24418055DERIVED

MeSH Terms

Conditions

Alzheimer Disease

Interventions

N-(5-(aminocarbonyl)tricyclo(3.3.1.13,7)dec-2-yl)-alpha,alpha-dimethyl-4-(5-(trifluoromethyl)-2-pyridinyl)-1-piperazineacetamideDonepezil

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

  • Gerard Marek, MD

    AbbVie

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

May 7, 2010

First Posted

June 4, 2010

Study Start

May 1, 2010

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

January 29, 2013

Record last verified: 2013-01

Locations

ZA(3)UA(9)GB(9)RU(9)