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

NCT ID: NCT01690195

Last Updated: 2021-08-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 343 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2014-02-28

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.

Detailed Description

This is a Phase 2, open-label, multicenter, 28 week extension study to evaluate the long-term safety and tolerability of ABT-126 in subjects who complete dosing through Week 24 of Study M11-793. Up to 420 subjects may participate at approximately 40 sites in seven countries.

Conditions

Alzheimer's Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ABT-126

ABT-126 Open-label dose

Group Type: EXPERIMENTAL

ABT-126

Intervention Type: DRUG

See arm description

Interventions

ABT-126

See arm description

Intervention Type: DRUG

Eligibility Criteria

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 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie (prior sponsor, Abbott)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laura Gault, MD

Role: STUDY_DIRECTOR

AbbVie

Locations

Site Reference ID/Investigator# 84185

Long Beach, California, United States

Site Reference ID/Investigator# 84183

San Francisco, California, United States

Site Reference ID/Investigator# 84187

Hamden, Connecticut, United States

Site Reference ID/Investigator# 84178

Delray Beach, Florida, United States

Site Reference ID/Investigator# 84180

Orlando, Florida, United States

Site Reference ID/Investigator# 84186

West Palm Beach, Florida, United States

Site Reference ID/Investigator# 84182

Elk Grove Village, Illinois, United States

Site Reference ID/Investigator# 84181

Staten Island, New York, United States

Site Reference ID/Investigator# 84179

Bennington, Vermont, United States

Site Reference ID/Investigator# 84173

Gatineau, , Canada

Site Reference ID/Investigator# 84174

Montreal, , Canada

Site Reference ID/Investigator# 84177

Peterborough, , Canada

Site Reference ID/Investigator# 84175

Toronto, , Canada

Site Reference ID/Investigator# 84176

Verdun, , Canada

Site Reference ID/Investigator# 84376

Dijon, , France

Site Reference ID/Investigator# 84373

Limoges, , France

Site Reference ID/Investigator# 84377

Paris, , France

Site Reference ID/Investigator# 84374

Paris, , France

Site Reference ID/Investigator# 84375

Toulouse, , France

Site Reference ID/Investigator# 84382

Berlin, , Germany

Site Reference ID/Investigator# 84380

Freiburg im Breisgau, , Germany

Site Reference ID/Investigator# 84383

Hüttenberg, , Germany

Site Reference ID/Investigator# 84379

Mittweida, , Germany

Site Reference ID/Investigator# 84381

Munich, , Germany

Site Reference ID/Investigator# 84378

Schwerin, , Germany

Site Reference ID/Investigator# 84385

Athens, , Greece

Site Reference ID/Investigator# 84388

Athens, , Greece

Site Reference ID/Investigator# 84389

Athens, , Greece

Site Reference ID/Investigator# 84386

Haidari, Athens, , Greece

Site Reference ID/Investigator# 84390

Thessaloniki, , Greece

Site Reference ID/Investigator# 84395

Belville, , South Africa

Site Reference ID/Investigator# 84391

Cape Town, , South Africa

Site Reference ID/Investigator# 84393

George, , South Africa

Site Reference ID/Investigator# 84394

Johannesburg, , South Africa

Site Reference ID/Investigator# 84392

Rosebank, , South Africa

Site Reference ID/Investigator# 84398

Bath, , United Kingdom

Site Reference ID/Investigator# 84397

Glasgow, , United Kingdom

Site Reference ID/Investigator# 84400

London, , United Kingdom

Site Reference ID/Investigator# 84399

Manchester, , United Kingdom

Countries

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

References

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.

Reference Type: RESULT

PMID: 26967214 (View on PubMed)

Other Identifiers

2012-000537-39

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

M11-428

Identifier Type: -

Identifier Source: org_study_id