Evaluate the Efficacy and Safety of ABT-126 in Subjects With Mild to Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors

Alzheimer's Disease Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ABT-126 in Subjects With Mild to Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01549834
• Other study ID #: M11-793
• Secondary ID: 2011-004849-40
• Status: Completed
• Phase: Phase 2
• First received: March 7, 2012
• Last updated: October 24, 2014
• Start date: March 2012
• Est. completion date: October 2013

Study information

• Verified date: October 2014
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited Kingdom: Medicines and Healthcare Products Regulatory AgencySouth Africa: Medicines Control CouncilCanada: Health CanadaGermany: Federal Institute for Drugs and Medical DevicesGreece: National Organization of MedicinesFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

This is an efficacy and safety study evaluating a new treatment for subjects with mild to moderate Alzheimer's disease.

Description:

This is a Phase 2 study designed to evaluate the efficacy and safety of ABT-126 in approximately 420 adults with mild to moderate Alzheimer's disease who are taking stable doses of acetylcholinesterase inhibitors. Subjects will be randomized to one of two ABT-126 dose arms or placebo for a 24-week treatment period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 434
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years to 90 Years

Eligibility

Inclusion Criteria:

• The subject and caregiver must voluntarily sign and date an informed consent. If the subject does not have the capacity to provide informed consent, full informed consent must be obtained from the subject's representative and assent must be obtained from the subject.

• The subject is a male or female between the ages of 55 and 90 years, inclusive, at Screening Visit 1. Main Inclusion (Continued):

• The subject meets the Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria for probable AD.

• The subject must be receiving a stable dose of an AChEI (donepezil or rivastigmine) for at least 90 days prior to Screening Visit 1.

• The subject has a Mini-Mental Status Examination (MMSE) total score of 12 to 24, inclusive, at Screening Visit 1.

• The subject has a Cornell Scale for Depression in Dementia (CSDD) score = 10 at Screening Visit 1.

• The subject has a Modified Hachinski Ischemic Scale (MHIS) score of = 4 at Screening Visit 1.

• With the exception of a diagnosis of mild-to-moderate Alzheimer's disease and the presence of stable medical conditions, the subject is in general good health, based upon the results of medical history, physical examination, vital signs, laboratory profile, and a 12-lead electrocardiogram (ECG).

• The subject has an identified, reliable caregiver who will provide support and ensure compliance with the study medication and procedures, and provide accurate information about the subject's status during the study.

Exclusion Criteria:

• The subject has taken galantamine or memantine within 60 days prior to Screening Visit 1.

• The subject has received excluded concomitant medications.

• The subject has clinically significant abnormal laboratory values at Screening Visit 1 as determined by the investigator.

• The subject has a history of any significant neurologic disease other than Alzheimer's disease including Parkinson's disease, multi-infarct or vascular dementia, Huntington's disease, normal pressure hydrocephalus, progressive supranuclear palsy, multiple sclerosis, any seizures, mental retardation or a history of significant head trauma followed by persistent neurologic deficits or known structural brain abnormalities.

• In the opinion of the investigator, the subject has any clinically significant uncontrolled medical or psychiatric illness.

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-126
Low Dose
• ABT-126
High Dose
• placebo
Placebo

Locations

Country	Name	City	State
Canada	Site Reference ID/Investigator# 71793	Gatineau
Canada	Site Reference ID/Investigator# 71794	Montreal
Canada	Site Reference ID/Investigator# 71798	Peterborough
Canada	Site Reference ID/Investigator# 71795	Toronto
Canada	Site Reference ID/Investigator# 71796	Verdun
France	Site Reference ID/Investigator# 71573	Dijon Cedex
France	Site Reference ID/Investigator# 77833	Limoges Cedex
France	Site Reference ID/Investigator# 68706	Paris
France	Site Reference ID/Investigator# 68704	Paris Cedex 10
France	Site Reference ID/Investigator# 68705	Toulouse Cedex 9
Germany	Site Reference ID/Investigator# 68768	Berlin
Germany	Site Reference ID/Investigator# 68764	Freiburg
Germany	Site Reference ID/Investigator# 68767	Huettenberg
Germany	Site Reference ID/Investigator# 69960	Mittweida
Germany	Site Reference ID/Investigator# 68765	Munich
Germany	Site Reference ID/Investigator# 69959	Schwerin
Greece	Site Reference ID/Investigator# 68730	Athens
Greece	Site Reference ID/Investigator# 68732	Athens
Greece	Site Reference ID/Investigator# 68733	Athens
Greece	Site Reference ID/Investigator# 68731	Haidari, Athens
Greece	Site Reference ID/Investigator# 68729	Thessaloniki
Greece	Site Reference ID/Investigator# 68735	Thessaloniki
South Africa	Site Reference ID/Investigator# 67586	Belville
South Africa	Site Reference ID/Investigator# 67582	Cape Town
South Africa	Site Reference ID/Investigator# 67584	George
South Africa	Site Reference ID/Investigator# 67585	Johannesburg
South Africa	Site Reference ID/Investigator# 67583	Rosebank
United Kingdom	Site Reference ID/Investigator# 67787	Bath
United Kingdom	Site Reference ID/Investigator# 67784	Glasgow
United Kingdom	Site Reference ID/Investigator# 67786	London
United Kingdom	Site Reference ID/Investigator# 67785	Manchester
United Kingdom	Site Reference ID/Investigator# 67783	Warrington
United States	Site Reference ID/Investigator# 66523	Bennington	Vermont
United States	Site Reference ID/Investigator# 66522	Delray Beach	Florida
United States	Site Reference ID/Investigator# 66526	Elk Grove Village	Illinois
United States	Site Reference ID/Investigator# 66528	Fresno	California
United States	Site Reference ID/Investigator# 66530	Hamden	Connecticut
United States	Site Reference ID/Investigator# 69602	Long Beach	California
United States	Site Reference ID/Investigator# 66524	Orlando	Florida
United States	Site Reference ID/Investigator# 66527	San Francisco	California
United States	Site Reference ID/Investigator# 66525	Staten Island	New York
United States	Site Reference ID/Investigator# 66531	Tampa	Florida
United States	Site Reference ID/Investigator# 66529	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie (prior sponsor, Abbott)

Countries where clinical trial is conducted

United States,  Canada,  France,  Germany,  Greece,  South Africa,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alzheimer's Disease Assessment Scale - cognitive subscale	An assessment tool which focuses on cognitive function and memory	Measurements up through 24 weeks	No
Secondary	Mini Mental Status Exam	Questionnaire which provides a quantitative measure of cognition	Measurements up through 24 weeks	No
Secondary	Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)	Caregiver-based assessment of activities of daily living	Measurements up through 24 weeks	No
Secondary	DEMentia Quality of Life (DEMQOL)	Health-related quality of life measurement tool	Measurements up through 24 weeks	No
Secondary	Clinician Interview-Based Impression of Change - plus (CIBIC-plus)	Measures a global impression of change in severity of dementia	Measurements up through 24 weeks	No
Secondary	Neuropsychiatry Inventory (NPI)	Assesses the presence of psychopathology in subjects with Alzheimer's disease and other dementias	Measurements up through 24 weeks	No
Secondary	Partner-Patient Questionnaire for Shared Activities (PPQSA)	Measures the extent to which mood and mental state interferes with the patient-partner relationship	Measurements up through 24 weeks	No
Secondary	Resource Use in Dementia (RUD-Lite)	Brief measurement tool for resource utilization	Measurements up through 24 weeks	No
Secondary	EuroQol-5D Questionnaires	Assesses patient's mobility, self-care, usual activity, pain/discomfort and anxiety/depression	Measurements up through 24 weeks	No
Secondary	Wechsler Memory Scale-III (WMS-III) Working Memory Index	Assesses working memory	Measurements up through 18 weeks	No