This 12-month open-label study will provide further information regarding the long-term safety and tolerability of intepirdine (RVT-101) for subjects with Alzheimer's disease who have completed the double-blind, placebo-controlled, lead-in study RVT-101-3001 (double-blind study).
This 12-month open-label study will provide further information regarding the long-term safety and tolerability of intepirdine (RVT-101) for subjects with Alzheimer's disease who have completed the double-blind, placebo-controlled, lead-in study RVT-101-3001. Various background therapies, including acetylcholinesterase inhibitors and memantine, will be allowed.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1,099
once daily, oral tablets
US112
Phoenix, Arizona, United States
US220
Tucson, Arizona, United States
US096
Rancho Mirage, California, United States
US195
Santa Ana, California, United States
US016
Simi Valley, California, United States
US106
Temecula, California, United States
US179
Hamden, Connecticut, United States
US171
Norwich, Connecticut, United States
US088
Atlantis, Florida, United States
US007
Brooksville, Florida, United States
...and 159 more locations
Occurrence of Adverse Events (AEs) and or Reported Changes in Physical Examinations, Vital Signs Measurements, Electrocardiograms (ECGs), Routine Laboratory Assessments
The primary outcome measure is to study the safety of Intepridine (RVT-101) by determining the incidence of AEs, changes in physical examinations, vital signs measurements, ECGs and clinical laboratory assessments
Time frame: Baseline to 12 months or Early Termination
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