NCT01549834

Evaluate the Efficacy and Safety of an Active Drug in Subjects With Mild to Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors

Brief summary

This is an efficacy and safety study evaluating a new treatment for subjects with mild to moderate Alzheimer's disease.

Interventional study

Status:
Completed
Conditions:
Alzheimer's Disease
Enrollment:
434 patients
Phase:
  • 1
  • 2
  • 3
  • 4
Protocol ID:
M11-793
Allocation:
Randomized
Intervention model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Purpose:
Treatment

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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 is a male or female between the ages of 55 and 90 years, inclusive, at
Screening Visit 1. Main Inclusion (Continued):

- The subject meets the Neurological and Communicative Disorders and Stroke/Alzheimer's
Disease and Related Disorders Association (NINCDS/ADRDA) criteria for probable AD.

- The subject must be receiving a stable dose of an AChEI (donepezil or rivastigmine)
for at least 90 days prior to Screening Visit 1.

- The subject has a Mini-Mental Status Examination (MMSE) total score of 12 to 24,
inclusive, at Screening Visit 1.

- The subject has a Cornell Scale for Depression in Dementia (CSDD) score ≤ 10 at
Screening Visit 1.

- The subject has a Modified Hachinski Ischemic Scale (MHIS) score of ≤ 4 at Screening
Visit 1.

- With the exception of a diagnosis of mild-to-moderate Alzheimer's disease 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 electrocardiogram (ECG).

- 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.

Exclusion Criteria:

- The subject has taken galantamine or memantine within 60 days prior to Screening Visit
1.

- The subject has received excluded concomitant medications.

- The subject has clinically significant abnormal laboratory values at Screening Visit 1
as determined by the investigator.

- The subject has a history of any significant neurologic disease other than Alzheimer's
disease including Parkinson's disease, multi-infarct or vascular dementia,
Huntington's disease, normal pressure hydrocephalus, progressive supranuclear palsy,
multiple sclerosis, any seizures, mental retardation or a history of significant head
trauma followed by persistent neurologic deficits or known structural brain
abnormalities.

- In the opinion of the investigator, the subject has any clinically significant
uncontrolled medical or psychiatric illness.

All the cities where the clinical studies are located

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