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

Alzheimer's Disease Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01690195
• Other study ID #: M11-428
• Secondary ID: 2012-000537-39
• Status: Terminated
• Phase: Phase 2
• Start date: September 2012
• Est. completion date: February 2014

Study information

• Verified date: July 2021
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 343
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• ABT-126
See arm description

Locations

Country	Name	City	State
Canada	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
France	Site Reference ID/Investigator# 84376	Dijon Cedex
France	Site Reference ID/Investigator# 84373	Limoges Cedex
France	Site Reference ID/Investigator# 84377	Paris
France	Site Reference ID/Investigator# 84374	Paris Cedex 10
France	Site Reference ID/Investigator# 84375	Toulouse Cedex 9
Germany	Site Reference ID/Investigator# 84382	Berlin
Germany	Site Reference ID/Investigator# 84380	Freiburg
Germany	Site Reference ID/Investigator# 84383	Huettenberg
Germany	Site Reference ID/Investigator# 84379	Mittweida
Germany	Site Reference ID/Investigator# 84381	Munich
Germany	Site Reference ID/Investigator# 84378	Schwerin
Greece	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
South Africa	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
United Kingdom	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 States	Site Reference ID/Investigator# 84179	Bennington	Vermont
United States	Site Reference ID/Investigator# 84178	Delray Beach	Florida
United States	Site Reference ID/Investigator# 84182	Elk Grove Village	Illinois
United States	Site Reference ID/Investigator# 84187	Hamden	Connecticut
United States	Site Reference ID/Investigator# 84185	Long Beach	California
United States	Site Reference ID/Investigator# 84180	Orlando	Florida
United States	Site Reference ID/Investigator# 84183	San Francisco	California
United States	Site Reference ID/Investigator# 84181	Staten Island	New York
United States	Site Reference ID/Investigator# 84186	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie (prior sponsor, Abbott)

Countries where clinical trial is conducted

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

References & 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-Bli — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Laboratory Data	Assessments include hematology, clinical chemistry, urinalysis and urine drug/alcohol screens	Assessments up through 28 weeks
Primary	Vital Signs	Assessments include pulse, blood pressure and oral body temperature	Assessments up through 28 weeks
Primary	Physical examinations	An examination of bodily functions and physical condition	Assessments up through 28 weeks
Primary	Brief Neurological examination	Assessments include cranial nerves, motor and sensory system, reflexes, coordination, gait and station	Assessments up through 28 weeks
Primary	Brief Psychiatric assessments	Assessments include mood, anxiety, psychosis or delusions, agitation, homicidal thoughts or behaviors	Assessments up through 28 weeks
Primary	Columbia-Suicide Severity Rating Scale	The scale is designed to assess suicidal behavior and ideation	Assessments up through 28 weeks
Primary	Cornell Scale for Depression in Dementia	Assesses the signs and symptoms of major depression in patients with dementia	Assessments up through 28 weeks
Primary	Electrocardiogram	Measurements include heart rate, RR interval, PR interval, QRS duration and QT intervals	Assessments up through 28 weeks