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

NCT ID: NCT01676935

Last Updated: 2021-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

349 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2014-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ABT-126

ABT-126 Open-label dose

Group Type EXPERIMENTAL

ABT-126

Intervention Type DRUG

See arm description

Interventions

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ABT-126

See arm description

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

55 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie (prior sponsor, Abbott)

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laura Gault, MD

Role: STUDY_DIRECTOR

AbbVie

Locations

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Site Reference ID/Investigator# 73493

Delray Beach, Florida, United States

Site Status

Site Reference ID/Investigator# 73496

West Palm Beach, Florida, United States

Site Status

Site Reference ID/Investigator# 73495

Elk Grove Village, Illinois, United States

Site Status

Site Reference ID/Investigator# 73494

Staten Island, New York, United States

Site Status

Site Reference ID/Investigator# 97035

Wichita Falls, Texas, United States

Site Status

Site Reference ID/Investigator# 73514

Poznan, , Poland

Site Status

Site Reference ID/Investigator# 73515

Szczecin, , Poland

Site Status

Site Reference ID/Investigator# 73516

Kazan', , Russia

Site Status

Site Reference ID/Investigator# 73525

Kazan', , Russia

Site Status

Site Reference ID/Investigator# 73523

Kirov, , Russia

Site Status

Site Reference ID/Investigator# 73521

Moscow, , Russia

Site Status

Site Reference ID/Investigator# 73519

Moscow, , Russia

Site Status

Site Reference ID/Investigator# 73517

Novosibirsk, , Russia

Site Status

Site Reference ID/Investigator# 73518

Saint Petersburg, , Russia

Site Status

Site Reference ID/Investigator# 73524

Saint Petersburg, , Russia

Site Status

Site Reference ID/Investigator# 84615

Saint Petersburg, , Russia

Site Status

Site Reference ID/Investigator# 73522

Saint Petersburg, , Russia

Site Status

Site Reference ID/Investigator# 73520

Saratov, , Russia

Site Status

Site Reference ID/Investigator# 73507

Belville, , South Africa

Site Status

Site Reference ID/Investigator# 84614

Cape Town, , South Africa

Site Status

Site Reference ID/Investigator# 73505

George, , South Africa

Site Status

Site Reference ID/Investigator# 73506

Johannesburg, , South Africa

Site Status

Site Reference ID/Investigator# 73533

Donetsk, , Ukraine

Site Status

Site Reference ID/Investigator# 73534

Kiev, , Ukraine

Site Status

Site Reference ID/Investigator# 73535

Poltava, , Ukraine

Site Status

Site Reference ID/Investigator# 73502

Bath, , United Kingdom

Site Status

Site Reference ID/Investigator# 73503

Blackburn, , United Kingdom

Site Status

Site Reference ID/Investigator# 73501

Glasgow, , United Kingdom

Site Status

Site Reference ID/Investigator# 73504

London, , United Kingdom

Site Status

Countries

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United States Poland Russia South Africa Ukraine United Kingdom

References

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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.

Reference Type RESULT
PMID: 27756421 (View on PubMed)

Other Identifiers

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2011-004780-75

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

M11-427

Identifier Type: -

Identifier Source: org_study_id

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