CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 132 enrolled
Drug / intervention
LY451395 +1 moredrug
Likely dose
3 mg LY451395 orally twice daily for 12 weeks (may be reduced to 1 mg if not tolerated)AI-extracted
Key inclusion· 7
  • ✓Probable Alzheimer's disease (AD) diagnosis per NINCDS/Alzheimer's Association criteria
  • ✓MMSE score 6–26 inclusive
  • ✓NPI-10 total score ≥10
  • ✓Age ≥60 years
Key exclusion· 6
  • ✕Delirium meeting DSM-IV-TR or Delirium Rating Scale-Revised-98 criteria
  • ✕Modified Hachinski Ischemia Scale >4 (vascular dementia risk)
  • ✕Brain imaging (MRI or CT) within 24 months inconsistent with AD diagnosis
  • ✕Current, required, or expected use of psychoactive drugs or other medications not allowed in trial

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00843518
NCT00843518Phase 2Completed
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Assessment of LY451395 for Neuropsychiatric Symptoms of Aggression and Agitation in Alzheimer's Disease

Eli Lilly and Company·interventional·Posted Feb 13, 2009·Updated Nov 29, 2017

In Brief

A Phase 2 clinical trial evaluating LY451395 and Placebo for Alzheimer's Disease. Completed, enrolled 132 participants across 17 sites.

Detailed Summary

The purpose of this study is to determine whether this drug can help symptoms of aggression and agitation in participants with Alzheimer's disease.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlzheimer's Disease
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 13, 2009
Enrollment StartFeb 1, 2009
Primary CompletionJun 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 17.4 years ago

Interventions

LY451395drug

3 mg LY451395 orally twice daily for 12 weeks; may have been reduced to 1 mg if participant was unable to tolerate

Placebodrug

Placebo orally twice daily for 12 weeks