Evidence map›Paper›PMID 34859493›Full record

Trial reportMovement disorders : official journal of the Movement Disorder Society2022

Safety and Efficacy of Mevidalen in Lewy Body Dementia: A Phase 2, Randomized, Placebo-Controlled Trial.

Kevin Biglan, Leanne Munsie, Kjell A Svensson, Paul Ardayfio, Melissa Pugh, John Sims, Miroslaw Brys

Open access · hybridAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Movement disorders : official journal of the Movement Disorder Society, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 1 pooled it
3.8field-weighted citation impact, top 6% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 1 synthesis or guideline pooled it, 37 citations in OpenAlex.

  1. The Signaling and Pharmacology of the Dopamine D1 Receptor.Frontiers in cellular neuroscience · 2021
    Pooled it
  2. [Dementia with Lewy bodies].Fortschritte der Neurologie-Psychiatrie · 2026
    Review
  3. Cardiovascular pharmacology of dopaminergic agents in humans: a review.Clinical autonomic research : official journal of the Clinical Autonomic Research Society · 2026
    Review
  4. Review
  5. Review
  6. Review
  7. Article
  8. Article
  9. Review
  10. Review
  11. Lewy Body Dementia: An Overview of Promising Therapeutics.Current neurology and neuroscience reports · 2023
    Review
  12. Article
  13. Article
  14. Review
  15. Review
  16. Review
  17. Article
  18. Race and Ethnicity in Lewy Body Dementia: A Narrative Review.Journal of Alzheimer's disease : JAD · 2023
    Review
  19. Review
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 1 institution in 1 country.

Kevin BiglanEli Lilly and Company, Indianapolis, Indiana, USA.ORCID 0000-0001-5114-3755
Leanne MunsieEli Lilly and Company, Indianapolis, Indiana, USA.
Kjell A SvenssonEli Lilly and Company, Indianapolis, Indiana, USA.
Paul ArdayfioEli Lilly and Company, Indianapolis, Indiana, USA.
Melissa PughEli Lilly and Company, Indianapolis, Indiana, USA.
John SimsEli Lilly and Company, Indianapolis, Indiana, USA.
Miroslaw BrysEli Lilly and Company, Indianapolis, Indiana, USA.
Eli Lilly (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMevidalen is a selective positive allosteric modulator (PAM) of the dopamine D1 receptor subtype.

objectiveTo assess the safety and efficacy of mevidalen for treatment of cognition in patients with Lewy body dementia (LBD).

methodsPRESENCE was a phase 2, 12-week study in participants with LBD (N = 344) randomly assigned (1:1:1:1) to daily doses of mevidalen (10, 30, or 75 mg) or placebo. The primary outcome measure was change from baseline on Cognitive Drug Research Continuity of Attention (CoA) composite score. Secondary outcomes included Alzheimer's Disease Assessment Scale-Cognitive Subscale 13 (ADAS-cog

resultsMevidalen failed to meet primary or secondary cognition endpoints. Mevidalen resulted in significant, dose-dependent improvements of MDS-UPDRS total score (sum of Parts I-III, 10 mg P < 0.05, 30 mg P < 0.05, 75 mg P < 0.01, compared to placebo). The 30 mg and 75 mg mevidalen doses significantly improved ADCS-CGIC scores compared to placebo (minimal or better improvement: 30 mg P < 0.01, 75 mg P < 0.01; moderate or better improvement: 30 mg P < 0.05, 75 mg P < 0.001). Increases in blood pressure, adverse events, and cardiovascular serious adverse events were most pronounced at the 75 mg dose.

conclusionsMevidalen harnesses a novel mechanism of action that improves motor symptoms associated with LBD on top of standard of care while improving or not worsening non-motor symptoms associated with traditional dopaminergic therapy. © 2021 The Authors. Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society.

Indexed as

Alzheimer DiseaseLewy Body DiseaseNeuroprotective AgentsCognitionDouble-Blind MethodHumansNeuroprotective Agentscognitiondopamine D1 receptorLewy body dementiamotor impairmentselective positive allosteric modulator (PAM)

Identifiers

PMID34859493
PMCPMC9300146
OpenAlexW3217029108

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.