Back to results

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

Primary Purpose

Alzheimer's Disease

Status

Terminated

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

ABT-126

About this trial

This is an interventional treatment trial for Alzheimer's Disease

Eligibility Criteria

55 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ABT-126

Arm Description

ABT-126 Open-label dose

Outcomes

Primary Outcome Measures

Adverse Events

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

Laboratory Data

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

Vital Signs

Assessments include pulse, blood pressure and oral body temperature

Physical examinations

An examination of bodily functions and physical condition

Brief Neurological examination

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

Brief Psychiatric assessments

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

Columbia-Suicide Severity Rating Scale

The scale is designed to assess suicidal behavior and ideation

Cornell Scale for Depression in Dementia

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

Electrocardiogram

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

Secondary Outcome Measures

Full Information

NCT ID

NCT01690195

First Posted

September 19, 2012

Last Updated

July 29, 2021

Sponsor

AbbVie (prior sponsor, Abbott)

1. Study Identification

Unique Protocol Identification Number

NCT01690195

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Terminated

Why Stopped

Data obtained from the M11-428 study is not critical to the continued evaluation of ABT-126.

Study Start Date

September 2012 (undefined)

Primary Completion Date

February 2014 (Actual)

Study Completion Date

February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AbbVie (prior sponsor, Abbott)

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer's Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

343 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ABT-126

Arm Type

Experimental

Arm Description

ABT-126 Open-label dose

Intervention Type

Drug

Intervention Name(s)

ABT-126

Intervention Description

See arm description

Primary Outcome Measure Information:

Title

Adverse Events

Description

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

Time Frame