Safety and Tolerability Study Evaluating a New Treatment for Subjects With Mild to Moderate Alzheimer's Disease

NCT01690195 | Terminated Phase 2

• 2 other identifiers: M11-4282012-000537-39
• Study Type: interventional
• Target: 343
• Locations: 7 countries
• Sites: 39

Brief Summary

This is a long term extension study to evaluate safety and tolerability of subjects who complete study M11-793 which is evaluating a new treatment for subjects with mild to moderate Alzheimer's disease on stable doses of acetylcholinesterase inhibitors.

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (9)

• Adverse Events

  Monitor each subject for clinical and laboratory evidence of adverse events on a routine basis throughout the study

  Assessments up through 28 weeks

• Laboratory Data

  Assessments include hematology, clinical chemistry, urinalysis and urine drug/alcohol screens

  Assessments up through 28 weeks

• Vital Signs

  Assessments include pulse, blood pressure and oral body temperature

  Assessments up through 28 weeks

• Physical examinations

  An examination of bodily functions and physical condition

  Assessments up through 28 weeks

• Brief Neurological examination

  Assessments include cranial nerves, motor and sensory system, reflexes, coordination, gait and station

  Assessments up through 28 weeks

• Brief Psychiatric assessments

  Assessments include mood, anxiety, psychosis or delusions, agitation, homicidal thoughts or behaviors

  Assessments up through 28 weeks

• Columbia-Suicide Severity Rating Scale

  The scale is designed to assess suicidal behavior and ideation

  Assessments up through 28 weeks

• Cornell Scale for Depression in Dementia

  Assesses the signs and symptoms of major depression in patients with dementia

  Assessments up through 28 weeks

• Electrocardiogram

  Measurements include heart rate, RR interval, PR interval, QRS duration and QT intervals

  Assessments up through 28 weeks

Study Arms (1)

ABT-126

EXPERIMENTAL

ABT-126 Open-label dose

Drug: ABT-126

Interventions

ABT-126 DRUG

See arm description

ABT-126

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 was randomized into Study M11-793 and completed dosing through Week 24 in that study.
• 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 ECG.
• If male, the subject is surgically sterile (vasectomy, is sexually inactive, or is using a barrier method of birth control (condom) with spermicidal foam/gel/film/cream/suppository for the duration of the study and for 30 days following the last dose of study drug. However, if the male subject's partner has been postmenopausal for at least two years or is surgically sterile, then use of a barrier method of birth control is not required.
• 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.
• The subject and caregiver must have sufficient visual, hearing and graphomotor skills to complete the study procedures.

You may not qualify if:

• The subject experienced an adverse event or abnormal finding in physical examination, vital signs, laboratory profile and/or ECG measurements in Study M11-793 that indicates the subject could become medically unstable during the current study.
• The subject is currently taking or is expected to be prescribed any excluded medications without the approval of Abbott medical monitor.
• The subject was noncompliant with donepezil or rivastigmine during Study M11-793 or is expected to discontinue these medications prior to conclusion of this study.
• The subject anticipates a move outside the geographic area of the investigative site or is planning extended travel inconsistent with the recommended visit intervals.
• The subject is currently enrolled in, or plans to participate in, another experimental study during the course of this trial.
• The subject developed any significant medical or psychiatric condition that, in the opinion of the investigator, renders the subject an unsuitable candidate to participate in this study.
• For any other reason the investigator considers the subject to be an unsuitable candidate to receive ABT-126 or to participate in this study.

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead

Study Sites (39)

Site Reference ID/Investigator# 84185

Long Beach, California, 90806, United States

Location

Site Reference ID/Investigator# 84183

San Francisco, California, 94109-4841, United States

Location

Site Reference ID/Investigator# 84187

Hamden, Connecticut, 06518, United States

Location

Site Reference ID/Investigator# 84178

Delray Beach, Florida, 33445, United States

Location

Site Reference ID/Investigator# 84180

Orlando, Florida, 32806, United States

Location

Site Reference ID/Investigator# 84186

West Palm Beach, Florida, 33407, United States

Location

Site Reference ID/Investigator# 84182

Elk Grove Village, Illinois, 60007, United States

Location

Site Reference ID/Investigator# 84181

Staten Island, New York, 10312, United States

Location

Site Reference ID/Investigator# 84179

Bennington, Vermont, 05201, United States

Location

Site Reference ID/Investigator# 84173

Gatineau, J9A 1K7, Canada

Location

Site Reference ID/Investigator# 84174

Montreal, H3T 1E2, Canada

Location

Site Reference ID/Investigator# 84177

Peterborough, K9H 2P4, Canada

Location

Site Reference ID/Investigator# 84175

Toronto, M3B 2S7, Canada

Location

Site Reference ID/Investigator# 84176

Verdun, H4H 1R3, Canada

Location

Site Reference ID/Investigator# 84376

Dijon, 21033, France

Location

Site Reference ID/Investigator# 84373

Limoges, 87042, France

Location

Site Reference ID/Investigator# 84377

Paris, 75013, France

Location

Site Reference ID/Investigator# 84374

Paris, 75475, France

Location

Site Reference ID/Investigator# 84375

Toulouse, 31059, France

Location

Site Reference ID/Investigator# 84382

Berlin, 14050, Germany

Location

Site Reference ID/Investigator# 84380

Freiburg im Breisgau, 79106, Germany

Location

Site Reference ID/Investigator# 84383

Hüttenberg, 35625, Germany

Location

Site Reference ID/Investigator# 84379

Mittweida, 09648, Germany

Location

Site Reference ID/Investigator# 84381

Munich, 81675, Germany

Location

Site Reference ID/Investigator# 84378

Schwerin, 19053, Germany

Location

Site Reference ID/Investigator# 84385

Athens, 115 21, Greece

Location

Site Reference ID/Investigator# 84388

Athens, 151 25, Greece

Location

Site Reference ID/Investigator# 84389

Athens, 15123, Greece

Location

Site Reference ID/Investigator# 84386

Haidari, Athens, 12462, Greece

Location

Site Reference ID/Investigator# 84390

Thessaloniki, 570 10, Greece

Location

Site Reference ID/Investigator# 84395

Belville, 7530, South Africa

Location

Site Reference ID/Investigator# 84391

Cape Town, 7405, South Africa

Location

Site Reference ID/Investigator# 84393

George, 6529, South Africa

Location

Site Reference ID/Investigator# 84394

Johannesburg, 2196, South Africa

Location

Site Reference ID/Investigator# 84392

Rosebank, 2196, South Africa

Location

Site Reference ID/Investigator# 84398

Bath, BA1 3NG, United Kingdom

Location

Site Reference ID/Investigator# 84397

Glasgow, G20 0XA, United Kingdom

Location

Site Reference ID/Investigator# 84400

London, TW8 8DS, United Kingdom

Location

Site Reference ID/Investigator# 84399

Manchester, M8 5RB, 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 RESULT

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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2012
• First Posted: September 21, 2012
• Study Start: September 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: August 2, 2021

Record last verified: 2021-07

Locations

GR (5); GB (4); US (9); CA (5); FR (5); DE (6); ZA (5)