Trial reportThe international journal of neuropsychopharmacology2020
A Neurofunctional Domains Approach to Evaluate D1/D5 Dopamine Receptor Partial Agonism on Cognition and Motivation in Healthy Volunteers With Low Working Memory Capacity.
Trial report in The international journal of neuropsychopharmacology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02306876 (A Randomized,Subject And Investigator Blind, Sponsor Open Placebo Controlled, Parallel Phase 1b Study To Examine The Safety, Pharmacokinetics, And Pharmacodynamic Effects Of Pf-06412562 On Cognitive And Reward/Motivation Domains In Healthy Male Volunteers Selected By Cognitive Phenotype), which is not on this map. Cited by 9 papers, 2 of them syntheses that pooled it.
What it found
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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.
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.
A Randomized,Subject And Investigator Blind, Sponsor Open Placebo Controlled, Parallel Phase 1b Study To Examine The Safety, Pharmacokinetics, And Pharmacodynamic Effects Of Pf-06412562 On Cognitive And Reward/Motivation Domains In Healthy Male Volunteers Selected By Cognitive Phenotype
Who cites it
9 citing papers in PubMed, 2 syntheses or guidelines pooled it, 12 citations in OpenAlex.
- Pooled it
- The Signaling and Pharmacology of the Dopamine D1 Receptor.Frontiers in cellular neuroscience · 2021Pooled it
- A Kpna1-deficient psychotropic drug-induced schizophrenia model mouse for studying gene-environment interactions.Scientific reports · 2024Article
- Rationale and Development of Tavapadon, a D1/D5-Selective Partial Dopamine Agonist for the Treatment of Parkinson's Disease.CNS & neurological disorders drug targets · 2024Review
- Effects of DPTQ, a novel positive allosteric modulator of the dopamine D1 receptor, on spontaneous eye blink rate and spatial working memory in the nonhuman primate.Psychopharmacology · 2023Article
- Experimental Medicine Approaches in Early-Phase CNS Drug Development.Advances in neurobiology · 2023Article
- Dopamine D1R Receptor Stimulation as a Mechanistic Pro-cognitive Target for Schizophrenia.Schizophrenia bulletin · 2022Article
- Dose-Dependent Regulation on Prefrontal Neuronal Working Memory by Dopamine DFrontiers in neuroscience · 2022Article
- Functional Selectivity of Dopamine DInternational journal of molecular sciences · 2021Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundDopamine D1 receptor signaling plays key roles in core domains of neural function, including cognition and reward processing; however, many questions remain about the functions of circuits modulated by dopamine D1 receptor, largely because clinically viable, selective agonists have yet to be tested in humans.
methodsUsing a novel, exploratory neurofunctional domains study design, we assessed the safety, tolerability, pharmacodynamics, and pharmacokinetics of PF-06412562, a selective D1/D5R partial agonist, in healthy male volunteers who met prespecified criteria for low working memory capacity. Functional magnetic resonance imaging, electrophysiologic endpoints, and behavioral paradigms were used to assess working memory, executive function, and motivation/reward processing following multiple-dose administration of PF-06412562. A total of 77 patients were assigned PF-06412562 (3 mg twice daily and 15 mg twice daily) or placebo administered for 5 to 7 days. Due to the exploratory nature of the study, it was neither powered for any specific treatment effect nor corrected for multiple comparisons.
resultsNominally significant improvements from baseline in cognitive endpoints were observed in all 3 groups; however, improvements in PF-06412562-treated patients were less than in placebo-treated participants. Motivation/reward processing endpoints were variable. PF-06412562 was safe and well tolerated, with no serious adverse events, severe adverse events, or adverse events leading to dose reduction or temporary discontinuation except for 1 permanent discontinuation due to increased orthostatic heart rate.
conclusionsPF-06412562, in the dose range and patient population explored in this study, did not improve cognitive function or motivation/reward processing more than placebo over the 5- to 7-day treatment period. CLINICALTRIALS.GOV IDENTIFIER: NCT02306876.
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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.