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

NCT01527916 | Completed Phase 2 DMC

• 2 other identifiers: M10-9852011-002004-32
• Study Type: interventional
• Target: 438
• Locations: 6 countries
• Sites: 33

Brief Summary

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

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

• Alzheimer's Disease Assessment Scale - cognitive subscale

  Measurements up through 24 weeks

Secondary Outcomes (9)

• Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)

  Measurements up through 24 weeks

• Mini Mental Status Exam (MMSE)

  Measurements up through 24 weeks

• DEMentia Quality of Life (DEMQOL)

  Measurements up through 24 weeks

• Clinician Interview-Based Impression of Change - plus (CIBIC-plus)

  Measurements up through 24 weeks

• Neuropsychiatry Inventory (NPI)

  Measurements up through 24 weeks

Study Arms (5)

sugar pill

PLACEBO COMPARATOR

Drug: placebo

donepezil

ACTIVE COMPARATOR

Drug: donepezil

ABT-126 Low Dose

EXPERIMENTAL

low dose

Drug: ABT-126

ABT-126 Middle Dose

EXPERIMENTAL

middle dose

Drug: ABT-126

ABT-126 high dose

EXPERIMENTAL

high dose

Drug: ABT-126

Interventions

placebo DRUG

Placebo Comparator

sugar pill

donepezil DRUG

Active Comparator

donepezil

ABT-126 DRUG

low dose, middle dose, high dose

ABT-126 Low Dose; ABT-126 Middle Dose; ABT-126 high dose

Eligibility Criteria

• Age: 55 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead

Study Sites (33)

Site Reference ID/Investigator# 56503

Delray Beach, Florida, 33445, United States

Location

Site Reference ID/Investigator# 56518

Tampa, Florida, 33613, United States

Location

Site Reference ID/Investigator# 56514

West Palm Beach, Florida, 33407, United States

Location

Site Reference ID/Investigator# 62611

Elk Grove Village, Illinois, 60007, United States

Location

Site Reference ID/Investigator# 56506

Staten Island, New York, 10312, United States

Location

Site Reference ID/Investigator# 82994

Jenkintown, Pennsylvania, 19046, United States

Location

Site Reference ID/Investigator# 77636

Wichita Falls, Texas, 76309, United States

Location

Site Reference ID/Investigator# 56504

Bennington, Vermont, 05201, United States

Location

Site Reference ID/Investigator# 62565

Gdynia, 81-361, Poland

Location

Site Reference ID/Investigator# 62563

Poznan, 61-853, Poland

Location

Site Reference ID/Investigator# 62562

Szczecin, 71-215, Poland

Location

Site Reference ID/Investigator# 60945

Kazan', 420012, Russia

Location

Site Reference ID/Investigator# 60955

Kazan', 420097, Russia

Location

Site Reference ID/Investigator# 60954

Kirov, 610014, Russia

Location

Site Reference ID/Investigator# 60951

Moscow, 119048, Russia

Location

Site Reference ID/Investigator# 60959

Moscow, 123995, Russia

Location

Site Reference ID/Investigator# 60946

Novosibirsk, 630064, Russia

Location

Site Reference ID/Investigator# 60947

Saint Petersburg, 190020, Russia

Location

Site Reference ID/Investigator# 60958

Saint Petersburg, 190103, Russia

Location

Site Reference ID/Investigator# 60949

Saint Petersburg, 192019, Russia

Location

Site Reference ID/Investigator# 60952

Saint Petersburg, 198510, Russia

Location

Site Reference ID/Investigator# 60950

Saratov, 410060, Russia

Location

Site Reference ID/Investigator# 60911

Belville, 7530, South Africa

Location

Site Reference ID/Investigator# 76073

Cape Town, 7925, South Africa

Location

Site Reference ID/Investigator# 60912

George, 6529, South Africa

Location

Site Reference ID/Investigator# 60910

Johannesburg, 2196, South Africa

Location

Site Reference ID/Investigator# 60909

Donetsk, 83037, Ukraine

Location

Site Reference ID/Investigator# 60906

Kiev, 04112, Ukraine

Location

Site Reference ID/Investigator# 60905

Poltava, 36006, Ukraine

Location

Site Reference ID/Investigator# 60960

Bath, BA1 3NG, United Kingdom

Location

Site Reference ID/Investigator# 60963

Blackburn, BB2 3HH, United Kingdom

Location

Site Reference ID/Investigator# 60962

Glasgow, G20 0XA, United Kingdom

Location

Site Reference ID/Investigator# 60961

London, TW8 8DS, United Kingdom

Location

Related Publications (1)

• Gault LM, Lenz RA, Ritchie CW, Meier A, Othman AA, Tang Q, Berry S, Pritchett Y, Robieson WZ. ABT-126 monotherapy in mild-to-moderate Alzheimer's dementia: randomized double-blind, placebo and active controlled adaptive trial and open-label extension. Alzheimers Res Ther. 2016 Oct 18;8(1):44. doi: 10.1186/s13195-016-0210-1.

  PMID: 27756421 DERIVED

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Donepezil; ABT-126

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Indans; Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Study Officials

• Laura Gault, 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: February 3, 2012
• First Posted: February 7, 2012
• Study Start: February 1, 2012
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: November 19, 2014

Record last verified: 2014-11

Locations

GB (4); RU (11); UA (3); ZA (4); US (8); PL (3)