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

July 29, 2021 updated by: AbbVie (prior sponsor, Abbott)

Long-Term Safety and Tolerability of ABT-126 in Adults With Mild-to-Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors: An Open-Label Extension Study for Subjects Completing Study M11-793

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
343

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Gatineau, Canada, J9A 1K7
        • Site Reference ID/Investigator# 84173
      • Montreal, Canada, H3T 1E2
        • Site Reference ID/Investigator# 84174
      • Peterborough, Canada, K9H 2P4
        • Site Reference ID/Investigator# 84177
      • Toronto, Canada, M3B 2S7
        • Site Reference ID/Investigator# 84175
      • Verdun, Canada, H4H 1R3
        • Site Reference ID/Investigator# 84176
  • France
      • Dijon Cedex, France, 21033
        • Site Reference ID/Investigator# 84376
      • Limoges Cedex, France, 87042
        • Site Reference ID/Investigator# 84373
      • Paris, France, 75013
        • Site Reference ID/Investigator# 84377
      • Paris Cedex 10, France, 75475
        • Site Reference ID/Investigator# 84374
      • Toulouse Cedex 9, France, 31059
        • Site Reference ID/Investigator# 84375
  • Germany
      • Berlin, Germany, 14050
        • Site Reference ID/Investigator# 84382
      • Freiburg, Germany, 79106
        • Site Reference ID/Investigator# 84380
      • Huettenberg, Germany, 35625
        • Site Reference ID/Investigator# 84383
      • Mittweida, Germany, 09648
        • Site Reference ID/Investigator# 84379
      • Munich, Germany, 81675
        • Site Reference ID/Investigator# 84381
      • Schwerin, Germany, 19053
        • Site Reference ID/Investigator# 84378
  • Greece
      • Athens, Greece, 115 21
        • Site Reference ID/Investigator# 84385
      • Athens, Greece, 151 25
        • Site Reference ID/Investigator# 84388
      • Athens, Greece, 15123
        • Site Reference ID/Investigator# 84389
      • Haidari, Athens, Greece, 12462
        • Site Reference ID/Investigator# 84386
      • Thessaloniki, Greece, 570 10
        • Site Reference ID/Investigator# 84390
  • South Africa
      • Belville, South Africa, 7530
        • Site Reference ID/Investigator# 84395
      • Cape Town, South Africa, 7405
        • Site Reference ID/Investigator# 84391
      • George, South Africa, 6529
        • Site Reference ID/Investigator# 84393
      • Johannesburg, South Africa, 2196
        • Site Reference ID/Investigator# 84394
      • Rosebank, South Africa, 2196
        • Site Reference ID/Investigator# 84392
  • United Kingdom
      • Bath, United Kingdom, BA1 3NG
        • Site Reference ID/Investigator# 84398
      • Glasgow, United Kingdom, G20 0XA
        • Site Reference ID/Investigator# 84397
      • London, United Kingdom, TW8 8DS
        • Site Reference ID/Investigator# 84400
      • Manchester, United Kingdom, M8 5RB
        • Site Reference ID/Investigator# 84399
  • United States
    • California
      • Long Beach, California, United States, 90806
        • Site Reference ID/Investigator# 84185
      • San Francisco, California, United States, 94109-4841
        • Site Reference ID/Investigator# 84183
    • Connecticut
      • Hamden, Connecticut, United States, 06518
        • Site Reference ID/Investigator# 84187
    • Florida
      • Delray Beach, Florida, United States, 33445
        • Site Reference ID/Investigator# 84178
      • Orlando, Florida, United States, 32806
        • Site Reference ID/Investigator# 84180
      • West Palm Beach, Florida, United States, 33407
        • Site Reference ID/Investigator# 84186
    • Illinois
      • Elk Grove Village, Illinois, United States, 60007
        • Site Reference ID/Investigator# 84182
    • New York
      • Staten Island, New York, United States, 10312
        • Site Reference ID/Investigator# 84181
    • Vermont
      • Bennington, Vermont, United States, 05201
        • Site Reference ID/Investigator# 84179

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

55 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ABT-126
ABT-126 Open-label dose
Drug: ABT-126
See arm description

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: Assessments up through 28 weeks
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
Time Frame: Assessments up through 28 weeks
Assessments include hematology, clinical chemistry, urinalysis and urine drug/alcohol screens
Assessments up through 28 weeks
Vital Signs
Time Frame: Assessments up through 28 weeks
Assessments include pulse, blood pressure and oral body temperature
Assessments up through 28 weeks
Physical examinations
Time Frame: Assessments up through 28 weeks
An examination of bodily functions and physical condition
Assessments up through 28 weeks
Brief Neurological examination
Time Frame: Assessments up through 28 weeks
Assessments include cranial nerves, motor and sensory system, reflexes, coordination, gait and station
Assessments up through 28 weeks
Brief Psychiatric assessments
Time Frame: Assessments up through 28 weeks
Assessments include mood, anxiety, psychosis or delusions, agitation, homicidal thoughts or behaviors
Assessments up through 28 weeks
Columbia-Suicide Severity Rating Scale
Time Frame: Assessments up through 28 weeks
The scale is designed to assess suicidal behavior and ideation
Assessments up through 28 weeks
Cornell Scale for Depression in Dementia
Time Frame: Assessments up through 28 weeks
Assesses the signs and symptoms of major depression in patients with dementia
Assessments up through 28 weeks
Electrocardiogram
Time Frame: Assessments up through 28 weeks
Measurements include heart rate, RR interval, PR interval, QRS duration and QT intervals
Assessments up through 28 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AbbVie (prior sponsor, Abbott)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Laura Gault, MD, AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 19, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 19, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 21, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 2, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 29, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • M11-428
  • 2012-000537-39 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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