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VI-1121

Phase 2

Alzheimer's Disease | Small molecule | Neurology |Medpace Holdings, Inc. Common Stock|Last Updated: Dec 11, 2013

Development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Sep 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment61

FDA Designations

No designations recorded

Clinical trial landscape

VI-1121 · 1 trial · 1 indication

Phase 2 1
NCT01428362VI-1121 for the Treatment Alzheimer's DiseaseAlzheimer's Disease
COMPLETED61 Analytics
PHASE2COMPLETED
VI-1121 for the Treatment Alzheimer's Disease
Alzheimer's DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

The primary efficacy variable is the change in Alzheimer's Disease Assessment-Cognitive Subscale (ADAS-Cog) score from baseline to Week 12 of each treatment period.
12 weeks

Secondary Endpoints

The secondary efficacy endpoint is the mean change in Mini-Mental State Examination (MMSE) score from baseline to Week 12 of each treatment period.
12 weeks
Percentage of subjects who achieve 3-point improvement in ADAS-Cog score from baseline to Week 12 of each treatment period.
12 Weeks
Change in Clinician's Interview Based Impression of Change Plus Caregiver's Input (CIBIC-plus) score from baseline to Week 12 of each treatment period
12 Weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Placebo/VI-1121EXPERIMENTALSubjects received placebo during first treatment period and active treatment with VI-1121 during the second treatment period.
VI-1121/PlaceboEXPERIMENTALSubjects received active treatment with VI-1121 during the first treatment period and placebo during the second treatment period.

Interventions

NameTypeDescription
VI-1121DRUG -
PlaceboDRUG -
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Eligibility Criteria

Age Range60 Years to 85 Years
SexALL
Healthy VolunteersNo
Study Sites11

Inclusion Criteria: * clinical diagnosis of Alzheimer's disease * CT or MRI within 2 years prior to study * stable dose of current Alzheimer's treatment for at least 3 months Exclusion Criteria: * advanced, severe, progressive or unstable disease * history of cerebrovascular disease or myocardial...

Countries:United States
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