Clinical trial NCT01676935: This is a 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 Subjects With Mild-to-Moderate Alzheimer's Disease: An Open-Label Extension Study for Subjects Completing Study M10-985
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Alzheimer's Disease
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2012-08-31
Enrollment: 349
Sex: ALL
Minimum age (years): 55
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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

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 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.

Primary outcomes:
measure: Adverse Events
timeFrame: Assessments up through 28 weeks
measure: Laboratory Data
timeFrame: Assessments up through 28 weeks
measure: Vital Signs
timeFrame: Assessments up through 28 weeks
measure: Physical examinations
timeFrame: Assessments up through 28 weeks
measure: Brief Neurological examination
timeFrame: Assessments up through 28 weeks
measure: Brief Psychiatric assessments
timeFrame: Assessments up through 28 weeks
measure: Columbia-Suicide Severity Rating Scale
timeFrame: Assessments up through 28 weeks
measure: Cornell Scale for Depression in Dementia
timeFrame: Assessments up through 28 weeks
measure: Electrocardiogram
timeFrame: Assessments up through 28 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Delray Beach
country: United States
facility: Site Reference ID/Investigator# 73493
state: Florida
city: West Palm Beach
country: United States
facility: Site Reference ID/Investigator# 73496
state: Florida
city: Elk Grove Village
country: United States
facility: Site Reference ID/Investigator# 73495
state: Illinois
city: Staten Island
country: United States
facility: Site Reference ID/Investigator# 73494
state: New York
city: Wichita Falls
country: United States
facility: Site Reference ID/Investigator# 97035
state: Texas
city: Poznan
country: Poland
facility: Site Reference ID/Investigator# 73514
city: Szczecin
country: Poland
facility: Site Reference ID/Investigator# 73515
city: Kazan
country: Russian Federation
facility: Site Reference ID/Investigator# 73516
city: Kazan
country: Russian Federation
facility: Site Reference ID/Investigator# 73525
city: Kirov
country: Russian Federation
facility: Site Reference ID/Investigator# 73523
city: Moscow
country: Russian Federation
facility: Site Reference ID/Investigator# 73521
city: Moscow
country: Russian Federation
facility: Site Reference ID/Investigator# 73519
city: Novosibirsk
country: Russian Federation
facility: Site Reference ID/Investigator# 73517
city: Saratov
country: Russian Federation
facility: Site Reference ID/Investigator# 73520
city: St. Petersburg
country: Russian Federation
facility: Site Reference ID/Investigator# 73518
city: St. Petersburg
country: Russian Federation
facility: Site Reference ID/Investigator# 73524
city: St. Petersburg
country: Russian Federation
facility: Site Reference ID/Investigator# 84615
city: St. Petersburg
country: Russian Federation
facility: Site Reference ID/Investigator# 73522
city: Belville
country: South Africa
facility: Site Reference ID/Investigator# 73507
city: Cape Town
country: South Africa
facility: Site Reference ID/Investigator# 84614
city: George
country: South Africa
facility: Site Reference ID/Investigator# 73505
city: Johannesburg
country: South Africa
facility: Site Reference ID/Investigator# 73506
city: Donetsk
country: Ukraine
facility: Site Reference ID/Investigator# 73533
city: Kiev
country: Ukraine
facility: Site Reference ID/Investigator# 73534
city: Poltava
country: Ukraine
facility: Site Reference ID/Investigator# 73535
city: Bath
country: United Kingdom
facility: Site Reference ID/Investigator# 73502
city: Blackburn
country: United Kingdom
facility: Site Reference ID/Investigator# 73503
city: Glasgow
country: United Kingdom
facility: Site Reference ID/Investigator# 73501
city: London
country: United Kingdom
facility: Site Reference ID/Investigator# 73504
Study officials:
affiliation: AbbVie
name: Laura Gault, MD
role: STUDY_DIRECTOR
References:
citation: 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. Alzheimers Res Ther. 2016 Oct 18;8(1):44. doi: 10.1186/s13195-016-0210-1.