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

NCT01549834 | Completed Phase 2 DMC

• 2 other identifiers: M11-7932011-004849-40
• Study Type: interventional
• Target: 434
• Locations: 7 countries
• Sites: 43

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

  An assessment tool which focuses on cognitive function and memory

  Measurements up through 24 weeks

Secondary Outcomes (9)

• Mini Mental Status Exam

  Measurements up through 24 weeks

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

  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 (3)

ABT-126 Low Dose

EXPERIMENTAL

low dose

Drug: ABT-126

ABT-126 High Dose

EXPERIMENTAL

high dose

Drug: ABT-126

sugar pill

PLACEBO COMPARATOR

Placebo

Drug: placebo

Interventions

ABT-126 DRUG

Low Dose

ABT-126 Low Dose

placebo DRUG

Placebo

sugar pill

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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead

Study Sites (43)

Site Reference ID/Investigator# 66528

Fresno, California, 93720, United States

Location

Site Reference ID/Investigator# 69602

Long Beach, California, 90806, United States

Location

Site Reference ID/Investigator# 66527

San Francisco, California, 94109-4841, United States

Location

Site Reference ID/Investigator# 66530

Hamden, Connecticut, 06518, United States

Location

Site Reference ID/Investigator# 66522

Delray Beach, Florida, 33445, United States

Location

Site Reference ID/Investigator# 66524

Orlando, Florida, 32806, United States

Location

Site Reference ID/Investigator# 66531

Tampa, Florida, 33613, United States

Location

Site Reference ID/Investigator# 66529

West Palm Beach, Florida, 33407, United States

Location

Site Reference ID/Investigator# 66526

Elk Grove Village, Illinois, 60007, United States

Location

Site Reference ID/Investigator# 66525

Staten Island, New York, 10312, United States

Location

Site Reference ID/Investigator# 66523

Bennington, Vermont, 05201, United States

Location

Site Reference ID/Investigator# 71793

Gatineau, J9A 1K7, Canada

Location

Site Reference ID/Investigator# 71794

Montreal, H3T 1E2, Canada

Location

Site Reference ID/Investigator# 71798

Peterborough, K9H 2P4, Canada

Location

Site Reference ID/Investigator# 71795

Toronto, M3B 2S7, Canada

Location

Site Reference ID/Investigator# 71796

Verdun, H4H 1R3, Canada

Location

Site Reference ID/Investigator# 71573

Dijon, 21033, France

Location

Site Reference ID/Investigator# 77833

Limoges, 87042, France

Location

Site Reference ID/Investigator# 68706

Paris, 75013, France

Location

Site Reference ID/Investigator# 68704

Paris, 75475, France

Location

Site Reference ID/Investigator# 68705

Toulouse, 31059, France

Location

Site Reference ID/Investigator# 68768

Berlin, 14050, Germany

Location

Site Reference ID/Investigator# 68764

Freiburg im Breisgau, 79106, Germany

Location

Site Reference ID/Investigator# 68767

Hüttenberg, 35625, Germany

Location

Site Reference ID/Investigator# 69960

Mittweida, 09648, Germany

Location

Site Reference ID/Investigator# 68765

Munich, 81675, Germany

Location

Site Reference ID/Investigator# 69959

Schwerin, 19053, Germany

Location

Site Reference ID/Investigator# 68730

Athens, 115 21, Greece

Location

Site Reference ID/Investigator# 68732

Athens, 151 25, Greece

Location

Site Reference ID/Investigator# 68733

Athens, 15123, Greece

Location

Site Reference ID/Investigator# 68731

Haidari, Athens, 12462, Greece

Location

Site Reference ID/Investigator# 68729

Thessaloniki, 56403, Greece

Location

Site Reference ID/Investigator# 68735

Thessaloniki, 570 10, Greece

Location

Site Reference ID/Investigator# 67586

Belville, 7530, South Africa

Location

Site Reference ID/Investigator# 67582

Cape Town, 7405, South Africa

Location

Site Reference ID/Investigator# 67584

George, 6529, South Africa

Location

Site Reference ID/Investigator# 67585

Johannesburg, 2196, South Africa

Location

Site Reference ID/Investigator# 67583

Rosebank, 2196, South Africa

Location

Site Reference ID/Investigator# 67787

Bath, BA1 3NG, United Kingdom

Location

Site Reference ID/Investigator# 67784

Glasgow, G20 0XA, United Kingdom

Location

Site Reference ID/Investigator# 67786

London, TW8 8DS, United Kingdom

Location

Site Reference ID/Investigator# 67785

Manchester, M8 5RB, United Kingdom

Location

Site Reference ID/Investigator# 67783

Warrington, WA2 8WA, United Kingdom

Location

Related Publications (1)

• Florian H, Meier A, Gauthier S, Lipschitz S, Lin Y, Tang Q, Othman AA, Robieson WZ, Gault LM. Efficacy and Safety of ABT-126 in Subjects with Mild-to-Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors: A Randomized, Double-Blind, Placebo-Controlled Study. J Alzheimers Dis. 2016;51(4):1237-47. doi: 10.3233/JAD-150978.

  PMID: 26967214 DERIVED

MeSH Terms

Conditions

Alzheimer Disease

Interventions

ABT-126

Condition Hierarchy (Ancestors)

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

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: March 7, 2012
• First Posted: March 9, 2012
• Study Start: March 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: October 31, 2014

Record last verified: 2014-10

Locations

US (11); DE (6); GR (6); ZA (5); GB (5); CA (5); FR (5)