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

Alzheimer's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01137526
• Other study ID #: M12-033
• Secondary ID: 2009 017801-12
• Status: Completed
• Phase: Phase 2
• First received: May 7, 2010
• Last updated: January 24, 2013
• Start date: May 2010
• Est. completion date: July 2011

Study information

• Verified date: January 2013
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: Research Ethics CommitteeRussia: Ministry of Health of the Russian FederationRussia: Ethics CommitteeUkraine: State Pharmacological Center - Ministry of HealthUkraine: Ministry of HealthSouth Africa: Medicines Control CouncilSouth Africa: Human Research Ethics CommitteeUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 267
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years to 90 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• ABT-384
Subjects will take study drug once daily for 12 weeks
• donepezil
Subjects will take study drug once daily for 12 weeks.
• placebo
Subjects will take study drug once daily for 12 weeks

Locations

Country	Name	City	State
Russian Federation	Site Reference ID/Investigator# 40834	Ekaterinburg
Russian Federation	Site Reference ID/Investigator# 36304	Kazan
Russian Federation	Site Reference ID/Investigator# 36306	Kirov
Russian Federation	Site Reference ID/Investigator# 37944	Moscow
Russian Federation	Site Reference ID/Investigator# 26909	Saratov
Russian Federation	Site Reference ID/Investigator# 26902	St. Petersburg
Russian Federation	Site Reference ID/Investigator# 26904	St. Petersburg
Russian Federation	Site Reference ID/Investigator# 36305	St. Petersburg
Russian Federation	Site Reference ID/Investigator# 38383	Yaroslavl
South Africa	Site Reference ID/Investigator# 45584	Belville
South Africa	Site Reference ID/Investigator# 47102	George
South Africa	Site Reference ID/Investigator# 45583	Johannesburg
Ukraine	Site Reference ID/Investigator# 39855	Donetsk
Ukraine	Site Reference ID/Investigator# 26914	Kharkiv
Ukraine	Site Reference ID/Investigator# 26912	Kiev
Ukraine	Site Reference ID/Investigator# 40484	Lviv
Ukraine	Site Reference ID/Investigator# 27002	Poltava
Ukraine	Site Reference ID/Investigator# 39856	Poltava
Ukraine	Site Reference ID/Investigator# 40482	Simferopil
Ukraine	Site Reference ID/Investigator# 40483	Ternopil
Ukraine	Site Reference ID/Investigator# 35660	Vinnytsia
United Kingdom	Site Reference ID/Investigator# 36327	Bath
United Kingdom	Site Reference ID/Investigator# 35657	Blackburn
United Kingdom	Site Reference ID/Investigator# 36330	Crowborough
United Kingdom	Site Reference ID/Investigator# 36326	Glasgow
United Kingdom	Site Reference ID/Investigator# 44123	Ivybridge, Devon
United Kingdom	Site Reference ID/Investigator# 35658	London
United Kingdom	Site Reference ID/Investigator# 35902	Northampton
United Kingdom	Site Reference ID/Investigator# 36328	Oxford
United Kingdom	Site Reference ID/Investigator# 36329	Peterborough

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie (prior sponsor, Abbott)

Countries where clinical trial is conducted

Russian Federation,  South Africa,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline to final observation in the Alzheimer's Disease Assessment Scale-Cognition portion (ADAS-cog) total score		12 Weeks	No
Secondary	Mini Mental Status Examination (MMSE) score at Baseline, Weeks 4, 8, and 12		12 Weeks	No
Secondary	Clinician's Interview Based Impression of Change-plus (CIBIC-plus) score at Baseline, Weeks 4, 8, and 12		12 Weeks	No
Secondary	Neuropsychiatric Inventory (NPI) score at Baseline, Weeks 4, 8, and 12		12 Weeks	No
Secondary	Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) score at Baseline, Weeks 4, 8, and 12		12 Weeks	No