Evaluate the Efficacy and Safety of ABT-126 in Subjects With Mild to Moderate Alzheimer's Disease

Alzheimer's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01527916
• Other study ID #: M10-985
• Secondary ID: 2011-002004-32
• Status: Completed
• Phase: Phase 2
• First received: February 3, 2012
• Last updated: November 6, 2014
• Start date: February 2012
• Est. completion date: November 2013

Study information

• Verified date: November 2014
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited States: Food and Drug AdministrationUnited Kingdom: Research Ethics CommitteeRussia: FSI Scientific Center of Expertise of Medical ApplicationUkraine: Ministry of HealthUkraine: Ethics CommitteeSouth Africa: Medicines Control CouncilSouth Africa: Human Research Ethics CommitteePoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsRussia: Ministry of Health of the Russian Federation
• 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 410 adults with mild to moderate Alzheimer's disease. Subjects will be randomized to one of 5 treatment groups (ABT-126, donepezil or placebo) for a 24-week treatment period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 438
• Est. completion date: November 2013
• Est. primary completion date: November 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.

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

• The subject has a Mini-Mental Status Examination (MMSE) total score of 10 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 AD 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 is currently taking or has taken a medication for the treatment of Alzheimer's disease or dementia within 60 days prior to Screening Visit 1, or is participating in cognitive therapy for the treatment of Alzheimer's disease or dementia.

• 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.

• The subject has a known hypersensitivity or intolerance to donepezil that lead to discontinuation or a known reported history of donepezil treatment failure.

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:
• placebo
Placebo Comparator
• donepezil
Active Comparator
• ABT-126
low dose, middle dose, high dose

Locations

Country	Name	City	State
Poland	Site Reference ID/Investigator# 62565	Gdynia
Poland	Site Reference ID/Investigator# 62563	Poznan
Poland	Site Reference ID/Investigator# 62562	Szczecin
Russian Federation	Site Reference ID/Investigator# 60945	Kazan
Russian Federation	Site Reference ID/Investigator# 60955	Kazan
Russian Federation	Site Reference ID/Investigator# 60954	Kirov
Russian Federation	Site Reference ID/Investigator# 60951	Moscow
Russian Federation	Site Reference ID/Investigator# 60959	Moscow
Russian Federation	Site Reference ID/Investigator# 60946	Novosibirsk
Russian Federation	Site Reference ID/Investigator# 60950	Saratov
Russian Federation	Site Reference ID/Investigator# 60947	St. Petersburg
Russian Federation	Site Reference ID/Investigator# 60949	St. Petersburg
Russian Federation	Site Reference ID/Investigator# 60952	St. Petersburg
Russian Federation	Site Reference ID/Investigator# 60958	St. Petersburg
South Africa	Site Reference ID/Investigator# 60911	Belville
South Africa	Site Reference ID/Investigator# 76073	Cape Town
South Africa	Site Reference ID/Investigator# 60912	George
South Africa	Site Reference ID/Investigator# 60910	Johannesburg
Ukraine	Site Reference ID/Investigator# 60909	Donetsk
Ukraine	Site Reference ID/Investigator# 60906	Kiev
Ukraine	Site Reference ID/Investigator# 60905	Poltava
United Kingdom	Site Reference ID/Investigator# 60960	Bath
United Kingdom	Site Reference ID/Investigator# 60963	Blackburn
United Kingdom	Site Reference ID/Investigator# 60962	Glasgow
United Kingdom	Site Reference ID/Investigator# 60961	London
United States	Site Reference ID/Investigator# 56504	Bennington	Vermont
United States	Site Reference ID/Investigator# 56503	Delray Beach	Florida
United States	Site Reference ID/Investigator# 62611	Elk Grove Village	Illinois
United States	Site Reference ID/Investigator# 82994	Jenkintown	Pennsylvania
United States	Site Reference ID/Investigator# 56506	Staten Island	New York
United States	Site Reference ID/Investigator# 56518	Tampa	Florida
United States	Site Reference ID/Investigator# 56514	West Palm Beach	Florida
United States	Site Reference ID/Investigator# 77636	Wichita Falls	Texas

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie (prior sponsor, Abbott)

Countries where clinical trial is conducted

United States,  Poland,  Russian Federation,  South Africa,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alzheimer's Disease Assessment Scale - cognitive subscale		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	Mini Mental Status Exam (MMSE)	Questionnaire which provides a quantitative measure of cognition	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 24 weeks	No