Clinical trial NCT01690195: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Alzheimer's Disease
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2012-09-21
Enrollment: 343
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 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.

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 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.

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: Long Beach
country: United States
facility: Site Reference ID/Investigator# 84185
state: California
city: San Francisco
country: United States
facility: Site Reference ID/Investigator# 84183
state: California
city: Hamden
country: United States
facility: Site Reference ID/Investigator# 84187
state: Connecticut
city: Delray Beach
country: United States
facility: Site Reference ID/Investigator# 84178
state: Florida
city: Orlando
country: United States
facility: Site Reference ID/Investigator# 84180
state: Florida
city: West Palm Beach
country: United States
facility: Site Reference ID/Investigator# 84186
state: Florida
city: Elk Grove Village
country: United States
facility: Site Reference ID/Investigator# 84182
state: Illinois
city: Staten Island
country: United States
facility: Site Reference ID/Investigator# 84181
state: New York
city: Bennington
country: United States
facility: Site Reference ID/Investigator# 84179
state: Vermont
city: Gatineau
country: Canada
facility: Site Reference ID/Investigator# 84173
city: Montreal
country: Canada
facility: Site Reference ID/Investigator# 84174
city: Peterborough
country: Canada
facility: Site Reference ID/Investigator# 84177
city: Toronto
country: Canada
facility: Site Reference ID/Investigator# 84175
city: Verdun
country: Canada
facility: Site Reference ID/Investigator# 84176
city: Dijon Cedex
country: France
facility: Site Reference ID/Investigator# 84376
city: Limoges Cedex
country: France
facility: Site Reference ID/Investigator# 84373
city: Paris Cedex 10
country: France
facility: Site Reference ID/Investigator# 84374
city: Paris
country: France
facility: Site Reference ID/Investigator# 84377
city: Toulouse Cedex 9
country: France
facility: Site Reference ID/Investigator# 84375
city: Berlin
country: Germany
facility: Site Reference ID/Investigator# 84382
city: Freiburg
country: Germany
facility: Site Reference ID/Investigator# 84380
city: Huettenberg
country: Germany
facility: Site Reference ID/Investigator# 84383
city: Mittweida
country: Germany
facility: Site Reference ID/Investigator# 84379
city: Munich
country: Germany
facility: Site Reference ID/Investigator# 84381
city: Schwerin
country: Germany
facility: Site Reference ID/Investigator# 84378
city: Athens
country: Greece
facility: Site Reference ID/Investigator# 84385
city: Athens
country: Greece
facility: Site Reference ID/Investigator# 84388
city: Athens
country: Greece
facility: Site Reference ID/Investigator# 84389
city: Haidari, Athens
country: Greece
facility: Site Reference ID/Investigator# 84386
city: Thessaloniki
country: Greece
facility: Site Reference ID/Investigator# 84390
city: Belville
country: South Africa
facility: Site Reference ID/Investigator# 84395
city: Cape Town
country: South Africa
facility: Site Reference ID/Investigator# 84391
city: George
country: South Africa
facility: Site Reference ID/Investigator# 84393
city: Johannesburg
country: South Africa
facility: Site Reference ID/Investigator# 84394
city: Rosebank
country: South Africa
facility: Site Reference ID/Investigator# 84392
city: Bath
country: United Kingdom
facility: Site Reference ID/Investigator# 84398
city: Glasgow
country: United Kingdom
facility: Site Reference ID/Investigator# 84397
city: London
country: United Kingdom
facility: Site Reference ID/Investigator# 84400
city: Manchester
country: United Kingdom
facility: Site Reference ID/Investigator# 84399
Study officials:
affiliation: AbbVie
name: Laura Gault, MD
role: STUDY_DIRECTOR
References:
citation: 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-Blind, Placebo-Controlled Study. J Alzheimers Dis. 2016;51(4):1237-47. doi: 10.3233/JAD-150978.