Efficacy and Safety Study of ABT-384 in Subjects With Mild-to-Moderate Alzheimer's Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01137526
First received: May 7, 2010
Last updated: January 24, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Alzheimer's Disease
Drug: ABT-384
Drug: donepezil
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo and Active-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of ABT-384 in Subjects With Mild-to-Moderate Alzheimer's Disease

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Change from baseline to final observation in the Alzheimer's Disease Assessment Scale-Cognition portion (ADAS-cog) total score [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mini Mental Status Examination (MMSE) score at Baseline, Weeks 4, 8, and 12 [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Clinician's Interview Based Impression of Change-plus (CIBIC-plus) score at Baseline, Weeks 4, 8, and 12 [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Neuropsychiatric Inventory (NPI) score at Baseline, Weeks 4, 8, and 12 [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) score at Baseline, Weeks 4, 8, and 12 [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

Enrollment: 267
Study Start Date: May 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ABT-384 Dose 1 Drug: ABT-384
Subjects will take study drug once daily for 12 weeks
Experimental: ABT-384 Dose 2 Drug: ABT-384
Subjects will take study drug once daily for 12 weeks
Active Comparator: donepezil Drug: donepezil
Subjects will take study drug once daily for 12 weeks.
Other Name: Aricept
Placebo Comparator: placebo Drug: placebo
Subjects will take study drug once daily for 12 weeks

Detailed Description:

This is a Phase 2 study designed to evaluate the safety and efficacy of ABT-384 in approximately 260 adults with mild-to-moderate Alzheimer's Disease (AD). Subjects will be randomized to one of four treatment groups (ABT-384, donepezil, or placebo) for a 12-week Treatment Period.

  Eligibility

Ages Eligible for Study:   55 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. Subject is male or female between the ages of 55 and 90 years of age, inclusive, at Day-1.
  3. Subject meets the NINCDS/ADRDA criteria for probable AD.
  4. Subject has a Mini-Mental Status Examination (MMSE) score of 10 to 24, inclusive, at Screening Visit 1.
  5. Subject has a Cornell Scale for Depression in Dementia (CSDD) score ≤ 10 at Screening Visit 1.
  6. 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.
  7. If female, subject must be postmenopausal for at least 2 years or surgically sterile.
  8. If male, the subject is surgically sterile (vasectomy), is sexually inactive, or is using a barrier method of birth control.
  9. 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.
  10. 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.

Exclusion Criteria:

  1. Subject has a known hypersensitivity or intolerance to donepezil that led to discontinuation or a known reported history of donepezil treatment failure.
  2. 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.
  3. 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.
  4. 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.
  5. 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.
  6. For any reason the investigator considers the subject to be an unsuitable candidate to receive ABT-384 or donepezil.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01137526

Locations
Russian Federation
Site Reference ID/Investigator# 40834
Ekaterinburg, Russian Federation, 620030
Site Reference ID/Investigator# 36304
Kazan, Russian Federation, 420097
Site Reference ID/Investigator# 36306
Kirov, Russian Federation, 610014
Site Reference ID/Investigator# 37944
Moscow, Russian Federation, 119048
Site Reference ID/Investigator# 26909
Saratov, Russian Federation, 410060
Site Reference ID/Investigator# 26904
St. Petersburg, Russian Federation, 190005
Site Reference ID/Investigator# 26902
St. Petersburg, Russian Federation, 190103
Site Reference ID/Investigator# 36305
St. Petersburg, Russian Federation, 198510
Site Reference ID/Investigator# 38383
Yaroslavl, Russian Federation, 150030
South Africa
Site Reference ID/Investigator# 45584
Belville, South Africa, 7530
Site Reference ID/Investigator# 47102
George, South Africa, 6529
Site Reference ID/Investigator# 45583
Johannesburg, South Africa, 2196
Ukraine
Site Reference ID/Investigator# 39855
Donetsk, Ukraine, 83003
Site Reference ID/Investigator# 26914
Kharkiv, Ukraine, 61177
Site Reference ID/Investigator# 26912
Kiev, Ukraine, 04114
Site Reference ID/Investigator# 40484
Lviv, Ukraine, 79010
Site Reference ID/Investigator# 27002
Poltava, Ukraine, 36006
Site Reference ID/Investigator# 39856
Poltava, Ukraine, 36024
Site Reference ID/Investigator# 40482
Simferopil, Ukraine, 95006
Site Reference ID/Investigator# 40483
Ternopil, Ukraine, 46020
Site Reference ID/Investigator# 35660
Vinnytsia, Ukraine, 21005
United Kingdom
Site Reference ID/Investigator# 36327
Bath, United Kingdom, BA1 3NG
Site Reference ID/Investigator# 35657
Blackburn, United Kingdom, BB2 3HH
Site Reference ID/Investigator# 36330
Crowborough, United Kingdom, TN6 1HB
Site Reference ID/Investigator# 36326
Glasgow, United Kingdom, G20 0XA
Site Reference ID/Investigator# 44123
Ivybridge, Devon, United Kingdom, PL21 9AB
Site Reference ID/Investigator# 35658
London, United Kingdom, TW8 8DS
Site Reference ID/Investigator# 35902
Northampton, United Kingdom, NN5 6UD
Site Reference ID/Investigator# 36328
Oxford, United Kingdom, OX3 9DU
Site Reference ID/Investigator# 36329
Peterborough, United Kingdom, PE2 7JU
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Gerard Marek, MD AbbVie
  More Information

No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01137526     History of Changes
Other Study ID Numbers: M12-033, 2009 017801-12
Study First Received: May 7, 2010
Last Updated: January 24, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee
Russia: Ministry of Health of the Russian Federation
Russia: Ethics Committee
Ukraine: State Pharmacological Center - Ministry of Health
Ukraine: Ministry of Health
South Africa: Medicines Control Council
South Africa: Human Research Ethics Committee
United States: Food and Drug Administration

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Donepezil
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014