NCT02880956

A Study to Evaluate the Efficacy and Safety of an Active Drug in Subjects With Early Alzheimer's Disease

Brief summary

This study seeks to evaluate the efficacy and safety of an active drug in subjects with Early Alzheimer's Disease.

Interventional study

Status:
Completed
Conditions:
Alzheimer's Disease
Enrollment:
453 patients
Phase:
  • 1
  • 2
  • 3
  • 4
Protocol ID:
M15-566
Allocation:
Randomized
Intervention model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Purpose:
Treatment

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Eligibility criteria

Participant attributes:
Male and Female

Age:

From 55 Years to 85 Years.

Inclusion Criteria:

- Subject who meets the National Institute on Aging and the Alzheimer's Association
(NIA-AA) clinical criteria for mild cognitive impairment or probable AD, and have:

- Clinical Dementia Rating (CDR)-Global Score of 0.5

- Mini-Mental State Examination (MMSE) score of 22 to 30, inclusive

- Repeatable Battery for the Assessment of Neuropsychological Status-Delayed Memory
Index (RBANS - DMI) score of 85 or lower

- Subject has a positive amyloid Positron Emission Tomography (PET) scan.

- Subject has a Modified Hachinski Ischemic Scale (MHIS) score of ≤ 4.

- The subject has an identified, reliable, study partner (e.g., family member).

- If using medications to treat symptoms related to AD, doses must be stable for at
least 12 weeks prior to randomization.

Exclusion Criteria:

- Subject has any contraindications or inability to tolerate brain magnetic resonance
imaging (MRI), PET scans or lumbar puncture.

- Subject has evidence of any other clinically significant neurological disorder other
than Early AD.

- In the opinion of the investigator, the subject has any clinically significant or
uncontrolled medical or psychiatric illness, or has had an infection requiring medical
intervention in the past 30 days.

- Subject has had a myocardial infarction, unstable angina, stroke, transient ischemic
attack or required intervention for any of these conditions within 6 months of
Screening.

All the cities where the clinical studies are located

Toronto - M3B 2S7