{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"omics_type":["Unknown"],"volume":["8(1)"],"submitter":["Nathan PJ"],"pubmed_abstract":["<h4>Introduction</h4>This study examined the safety and pharmacodynamic effects of selective muscarinic M<sub>1</sub> receptor orthosteric agonist HTL0018318 in 60 patients with mild-to-moderate Alzheimer's disease (AD) on background donepezil 10 mg/day.<h4>Methods</h4>A randomized, double-blind, placebo-controlled 4-week safety study of HTL0018318 with up-titration and maintenance phases, observing exploratory effects on electrophysiological biomarkers and cognition.<h4>Results</h4>Treatment-emergent adverse events (TEAEs) were mild and less frequently reported during maintenance versus titration. Headache was most commonly reported (7-21%); 0 to 13% reported cholinergic TEAEs (abdominal pain, diarrhea, fatigue, nausea) and two patients discontinued due to TEAEs. At 1 to 2 hours post-dose"],"journal":["Alzheimer's & dementia (New York, N. Y.)"],"pagination":["e12273"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC8864442"],"repository":["biostudies-literature"],"pubmed_title":["A phase 1b/2a multicenter study of the safety and preliminary pharmacodynamic effects of selective muscarinic M<sub>1</sub> receptor agonist HTL0018318 in patients with mild-to-moderate Alzheimer's disease."],"pmcid":["PMC8864442"],"pubmed_authors":["Bakker G","Cross DM","Congreve M","Jones SP","Nathan PJ","Godwood A","Ruparelia B","Tasker T","Millais SB","Maruff PT","Dewit O","Liptrot J","Brown AJH","Light GA","Weir MP"],"additional_accession":[]},"is_claimable":false,"name":"A phase 1b/2a multicenter study of the safety and preliminary pharmacodynamic effects of selective muscarinic M<sub>1</sub> receptor agonist HTL0018318 in patients with mild-to-moderate Alzheimer's disease.","description":"<h4>Introduction</h4>This study examined the safety and pharmacodynamic effects of selective muscarinic M<sub>1</sub> receptor orthosteric agonist HTL0018318 in 60 patients with mild-to-moderate Alzheimer's disease (AD) on background donepezil 10 mg/day.<h4>Methods</h4>A randomized, double-blind, placebo-controlled 4-week safety study of HTL0018318 with up-titration and maintenance phases, observing exploratory effects on electrophysiological biomarkers and cognition.<h4>Results</h4>Treatment-emergent adverse events (TEAEs) were mild and less frequently reported during maintenance versus titration. Headache was most commonly reported (7-21%); 0 to 13% reported cholinergic TEAEs (abdominal pain, diarrhea, fatigue, nausea) and two patients discontinued due to TEAEs. At 1 to 2 hours post-dose","dates":{"release":"2022-01-01T00:00:00Z","publication":"2022","modification":"2026-06-18T06:00:41.256Z","creation":"2025-04-05T21:04:11.366Z"},"accession":"S-EPMC8864442","cross_references":{"pubmed":["35229025"],"doi":["10.1002/trc2.12273"]}}