NCT01690195

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

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.

Interventional study

Status:
Terminated
Conditions:
Alzheimer's Disease
Enrollment:
343 patients
Phase:
  • 1
  • 2
  • 3
  • 4
Protocol ID:
M11-428
Allocation:
N/A
Intervention model:
Single Group Assignment
Masking:
None (Open Label)
Purpose:
Treatment

Would you like to know more about this trial?

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Eligibility criteria

Participant attributes:
Male and Female

Age:

From 55 Years to 90 Years.

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.

All the cities where the clinical studies are located

Peterborough - K9H 2P4
Toronto - M3B 2S7
Gatineau - J9A 1K7
Montreal - H3T 1E2
Verdun - H4H 1R3