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NCT02871427

Open-label Study of Nelotanserin in Lewy Body Dementia With Visual Hallucinations or REM Sleep Behavior Disorder

Terminated Phase 2 Last updated 27 March 2019
What this trial tests

Phase 2 trial testing Nelotanserin in Lewy Body Dementia in 80 participants. Terminated before completion.

Timeline
20 October 2016
Primary endpoint
17 January 2019
17 January 2019

Quick facts

Lead sponsorAxovant Sciences Ltd.
PhasePhase 2
StatusTerminated
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment80
Start date20 October 2016
Primary completion17 January 2019
Estimated completion17 January 2019
Sites19 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Axovant Sciences Ltd. — full company profile →

Who can join

50 and older, any sex, with Lewy Body Dementia or Dementia With Lewy Bodies. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study seeks to evaluate the long-term safety and effectiveness of nelotanserin for the treatment of visual hallucinations (VHs) and Rapid Eye Movement (REM) Sleep Behavior Disorder (RBD) in subjects with Lewy body dementia (LBD).

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Proteostasis failure exacerbates neuronal circuit dysfunction and sleep impairments in Alzheimer's disease.
    Morrone CD, Raghuraman R, Hussaini SA, Yu WH. · · 2023 · cited 40× · PMID 37085942 · DOI 10.1186/s13024-023-00617-4
  2. A critical review of the pharmacological treatment of REM sleep behavior disorder in adults: time for more and larger randomized placebo-controlled trials.
    Gilat M, Marshall NS, Testelmans D, Buyse B, et al · · 2022 · cited 36× · PMID 33410930 · DOI 10.1007/s00415-020-10353-0
  3. Advances in dementia with Lewy bodies.
    Armstrong MJ. · · 2021 · cited 20× · PMID 34840608 · DOI 10.1177/17562864211057666
  4. Drug Discovery and Development Targeting Dementia.
    Zagórska A, Czopek A, Fryc M, Jaromin A, et al · · 2023 · cited 18× · PMID 37259302 · DOI 10.3390/ph16020151
  5. Novel Treatment Opportunities Against Cognitive Impairment in Parkinson's Disease with an Emphasis on Diabetes-Related Pathways.
    Green H, Tsitsi P, Markaki I, Aarsland D, et al · · 2019 · cited 17× · PMID 30687888 · DOI 10.1007/s40263-018-0601-x
  6. Lewy Body Dementias: Controversies and Drug Development.
    Chiu SY, Bowers D, Armstrong MJ. · · 2022 · cited 5× · PMID 34859379 · DOI 10.1007/s13311-021-01161-z

Verify or expand the search:

Other recruiting trials for Lewy Body Dementia

Currently open trials in the same condition.

Other Axovant Sciences Ltd. trials

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