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

NCT01676935 | Terminated Phase 2

• 2 other identifiers: M11-4272011-004780-75
• Study Type: interventional
• Target: 349
• Locations: 6 countries
• Sites: 29

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.

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (9)

• 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

• Laboratory Data

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

  Assessments up through 28 weeks

• Vital Signs

  Assessments include pulse, blood pressure and oral body temperature

  Assessments up through 28 weeks

• Physical examinations

  An examination of bodily functions and physical condition

  Assessments up through 28 weeks

• Brief Neurological examination

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

  Assessments up through 28 weeks

• Brief Psychiatric assessments

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

  Assessments up through 28 weeks

• Columbia-Suicide Severity Rating Scale

  The scale is designed to assess suicidal behavior and ideation

  Assessments up through 28 weeks

• Cornell Scale for Depression in Dementia

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

  Assessments up through 28 weeks

• Electrocardiogram

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

  Assessments up through 28 weeks

Study Arms (1)

ABT-126

EXPERIMENTAL

ABT-126 Open-label dose

Drug: ABT-126

Interventions

ABT-126 DRUG

See arm description

ABT-126

Eligibility Criteria

• Age: 55 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead

Study Sites (29)

Site Reference ID/Investigator# 73493

Delray Beach, Florida, 33445, United States

Location

Site Reference ID/Investigator# 73496

West Palm Beach, Florida, 33407, United States

Location

Site Reference ID/Investigator# 73495

Elk Grove Village, Illinois, 60007, United States

Location

Site Reference ID/Investigator# 73494

Staten Island, New York, 10312, United States

Location

Site Reference ID/Investigator# 97035

Wichita Falls, Texas, 76309, United States

Location

Site Reference ID/Investigator# 73514

Poznan, 61-853, Poland

Location

Site Reference ID/Investigator# 73515

Szczecin, 71-215, Poland

Location

Site Reference ID/Investigator# 73516

Kazan', 420012, Russia

Location

Site Reference ID/Investigator# 73525

Kazan', 420097, Russia

Location

Site Reference ID/Investigator# 73523

Kirov, 610014, Russia

Location

Site Reference ID/Investigator# 73521

Moscow, 119048, Russia

Location

Site Reference ID/Investigator# 73519

Moscow, 123995, Russia

Location

Site Reference ID/Investigator# 73517

Novosibirsk, 630064, Russia

Location

Site Reference ID/Investigator# 73518

Saint Petersburg, 190020, Russia

Location

Site Reference ID/Investigator# 73524

Saint Petersburg, 190103, Russia

Location

Site Reference ID/Investigator# 84615

Saint Petersburg, 192019, Russia

Location

Site Reference ID/Investigator# 73522

Saint Petersburg, 198510, Russia

Location

Site Reference ID/Investigator# 73520

Saratov, 410060, Russia

Location

Site Reference ID/Investigator# 73507

Belville, 7530, South Africa

Location

Site Reference ID/Investigator# 84614

Cape Town, 7925, South Africa

Location

Site Reference ID/Investigator# 73505

George, 6529, South Africa

Location

Site Reference ID/Investigator# 73506

Johannesburg, 2196, South Africa

Location

Site Reference ID/Investigator# 73533

Donetsk, 83037, Ukraine

Location

Site Reference ID/Investigator# 73534

Kiev, 04112, Ukraine

Location

Site Reference ID/Investigator# 73535

Poltava, 36006, Ukraine

Location

Site Reference ID/Investigator# 73502

Bath, BA1 3NG, United Kingdom

Location

Site Reference ID/Investigator# 73503

Blackburn, BB2 3HH, United Kingdom

Location

Site Reference ID/Investigator# 73501

Glasgow, G20 0XA, United Kingdom

Location

Site Reference ID/Investigator# 73504

London, TW8 8DS, United Kingdom

Location

Related 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. Alzheimers Res Ther. 2016 Oct 18;8(1):44. doi: 10.1186/s13195-016-0210-1.

  PMID: 27756421 RESULT

MeSH Terms

Conditions

Alzheimer Disease

Interventions

ABT-126

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Laura Gault, MD

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2012
• First Posted: August 31, 2012
• Study Start: August 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: August 2, 2021

Record last verified: 2021-07

Locations

US (5); PL (2); ZA (4); UA (3); GB (4); RU (11)