This is a 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 Subjects With Mild-to-Moderate Alzheimer's Disease: An Open-Label Extension Study for Subjects Completing Study M10-985

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01676935
• Other study ID #: M11-427
• Secondary ID: 2011-004780-75
• Status: Terminated
• Phase: Phase 2
• Start date: August 2012
• Est. completion date: March 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 M10-985 which is evaluating a new treatment for subjects with mild to moderate Alzheimer's disease.

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 M10-985. Up to 410 subjects may participate at approximately 30 sites in several countries.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 349
• Est. completion date: March 2014
• Est. primary completion date: March 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 M10-985 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 2 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:

• Experienced an adverse event or abnormal finding in physical examination, vital signs, laboratory profile and/or ECG measurements in Study M10-985 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 (including acetylcholinesterase inhibitors or memantine), without the approval of Abbott medical monitor. - 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
Poland	Site Reference ID/Investigator# 73514	Poznan
Poland	Site Reference ID/Investigator# 73515	Szczecin
Russian Federation	Site Reference ID/Investigator# 73516	Kazan
Russian Federation	Site Reference ID/Investigator# 73525	Kazan
Russian Federation	Site Reference ID/Investigator# 73523	Kirov
Russian Federation	Site Reference ID/Investigator# 73519	Moscow
Russian Federation	Site Reference ID/Investigator# 73521	Moscow
Russian Federation	Site Reference ID/Investigator# 73517	Novosibirsk
Russian Federation	Site Reference ID/Investigator# 73520	Saratov
Russian Federation	Site Reference ID/Investigator# 73518	St. Petersburg
Russian Federation	Site Reference ID/Investigator# 73522	St. Petersburg
Russian Federation	Site Reference ID/Investigator# 73524	St. Petersburg
Russian Federation	Site Reference ID/Investigator# 84615	St. Petersburg
South Africa	Site Reference ID/Investigator# 73507	Belville
South Africa	Site Reference ID/Investigator# 84614	Cape Town
South Africa	Site Reference ID/Investigator# 73505	George
South Africa	Site Reference ID/Investigator# 73506	Johannesburg
Ukraine	Site Reference ID/Investigator# 73533	Donetsk
Ukraine	Site Reference ID/Investigator# 73534	Kiev
Ukraine	Site Reference ID/Investigator# 73535	Poltava
United Kingdom	Site Reference ID/Investigator# 73502	Bath
United Kingdom	Site Reference ID/Investigator# 73503	Blackburn
United Kingdom	Site Reference ID/Investigator# 73501	Glasgow
United Kingdom	Site Reference ID/Investigator# 73504	London
United States	Site Reference ID/Investigator# 73493	Delray Beach	Florida
United States	Site Reference ID/Investigator# 73495	Elk Grove Village	Illinois
United States	Site Reference ID/Investigator# 73494	Staten Island	New York
United States	Site Reference ID/Investigator# 73496	West Palm Beach	Florida
United States	Site Reference ID/Investigator# 97035	Wichita Falls	Texas

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie (prior sponsor, Abbott)

Countries where clinical trial is conducted

United States,  Poland,  Russian Federation,  South Africa,  Ukraine,  United Kingdom, 

References & Publications (1)

Gault LM, Lenz RA, Ritchie CW, Meier A, Othman AA, Tang Q, Berry S, Pritchett Y, Robieson WZ. ABT-126 monotherapy in mild-to-moderate Alzheimer's dementia: randomized double-blind, placebo and active controlled adaptive trial and open-label extension. Alz — 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