CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 79 enrolled
Drug / intervention
Pimavanserindrug
Likely dose
Pimavanserin 20 mg or 34 mg once daily by mouthAI-extracted
Key inclusion· 5
  • ✓Must have completed Week 12 visit in Study ACP-103-032 while on assigned blinded study drug
  • ✓Able to understand trial nature and provide informed consent (patient or legally authorized representative with patient assent)
  • ✓Lives at home, assisted living, or care facility with capacity to attend clinic visits
  • ✓Has designated caregiver/study partner in contact at least 3 times per week on 3 separate days
Key exclusion· 6
  • ✕Was significantly non-compliant in prior study ACP-103-032
  • ✕Impending unexpected change in living situation (change in caregiver, facility, or residence) that may disrupt behavior
  • ✕Patient or caregiver has medical condition (hearing, vision impairment) impairing ability to perform study assessments
  • ✕Patient is bedridden or has unstable significant medical condition placing patient at undue risk from study drug or procedures

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

Search/NCT03118947
NCT03118947Phase 2Completed
CompareCT.gov

A 52-Week Open-Label Extension Study of Pimavanserin for the Treatment of Agitation and Aggression in Subjects With Alzheimer's Disease

ACADIA Pharmaceuticals Inc.·interventional·Posted Apr 18, 2017·Updated Apr 9, 2020

In Brief

A Phase 2 clinical trial evaluating Pimavanserin for Agitation and Aggression in Alzheimer's Disease. Completed, enrolled 79 participants across 28 sites in 5 countries.

Detailed Summary

To evaluate the safety and tolerability of pimavanserin over 52 weeks of treatment in subjects with probable AD who have symptoms of agitation and aggression

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAgitation and Aggression in Alzheimer's Disease
CountriesChile, France, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedApr 18, 2017
Enrollment StartFeb 23, 2017
Primary CompletionFeb 25, 2019
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 9.2 years ago

Interventions

Pimavanserindrug

Pimavanserin 20 mg, tablet, taken as two 10 mg tablets, once daily by mouth, OR Pimavanserin 34 mg, tablet, taken as two 17 mg tablets, once daily by mouth