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Record W4397009139 · doi:10.1038/s41591-024-02977-w

p75 neurotrophin receptor modulation in mild to moderate Alzheimer disease: a randomized, placebo-controlled phase 2a trial

2024· article· en· W4397009139 on OpenAlexafffund
Hayley R. C. Shanks, Kewei Chen, Eric M. Reiman, Kaj Blennow, Jeffrey L. Cummings, Stephen M. Massa, Frank M. Longo, Anne Börjesson‐Hanson, Manfred Windisch, Taylor W. Schmitz

Bibliographic record

VenueNature Medicine · 2024
Typearticle
Languageen
FieldNeuroscience
TopicNerve injury and regeneration
Canadian institutionsRobarts Clinical TrialsWestern University
FundersNational Institute on AgingCanadian Institutes of Health ResearchGenentechNational Institutes of HealthIXICONational Institute of General Medical SciencesH. Lundbeck A/SServierGöteborgs UniversitetAlzheimer's Drug Discovery FoundationKarolinska InstitutetVetenskapsrådetEisaiBristol-Myers SquibbGovernment of OntarioNorthern California Institute for Research and EducationPfizerBiogenBioClinicaFondation pour la Recherche sur AlzheimerAlzheimer's SocietyUniversity of Southern CaliforniaHjärnfondenF. Hoffmann-La RocheGovernment of CanadaU.S. Department of DefenseEli Lilly and CompanyMedizinische Universität GrazAlzheimer's AssociationKarl-Franzens-Universität GrazU.S. Department of Health and Human ServicesFoundation for the National Institutes of Health
KeywordsPlaceboClinical endpointTolerabilityMedicineRandomized controlled trialClinical trialInternal medicineOncologyAlzheimer's diseasePharmacologyAdverse effectPathologyDisease

Abstract

fetched live from OpenAlex

Abstract p75 neurotrophin receptor (p75 NTR ) signaling pathways substantially overlap with degenerative networks active in Alzheimer disease (AD). Modulation of p75 NTR with the first-in-class small molecule LM11A-31 mitigates amyloid-induced and pathological tau-induced synaptic loss in preclinical models. Here we conducted a 26-week randomized, placebo-controlled, double-blinded phase 2a safety and exploratory endpoint trial of LM11A-31 in 242 participants with mild to moderate AD with three arms: placebo, 200 mg LM11A-31 and 400 mg LM11A-31, administered twice daily by oral capsules. This trial met its primary endpoint of safety and tolerability. Within the prespecified secondary and exploratory outcome domains (structural magnetic resonance imaging, fluorodeoxyglucose positron-emission tomography and cerebrospinal fluid biomarkers), significant drug–placebo differences were found, consistent with the hypothesis that LM11A-31 slows progression of pathophysiological features of AD; no significant effect of active treatment was observed on cognitive tests. Together, these results suggest that targeting p75 NTR with LM11A-31 warrants further investigation in larger-scale clinical trials of longer duration. EU Clinical Trials registration: 2015-005263-16 ; ClinicalTrials.gov registration: NCT03069014 .

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

How this classification was reachedexpand

Full frame distilled prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.

metaresearch head score (Codex)0.001
metaresearch head score (Gemma)0.003
Version: codex-gemma-dda1882f352aValidation status: machine_predicted_unvalidated
Candidate categoriesnone
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Randomized trial · Consensus signal: Randomized trial
GenreCandidate signal: Empirical · Consensus signal: Empirical
Teacher disagreement score0.192
Threshold uncertainty score0.687

Codex and Gemma teacher scores by category

CategoryCodexGemma
Metaresearch0.0010.003
Meta-epidemiology (narrow)0.0000.000
Meta-epidemiology (broad)0.0010.000
Bibliometrics0.0000.001
Science and technology studies0.0000.000
Scholarly communication0.0000.000
Open science0.0000.000
Research integrity0.0000.001
Insufficient payload (model declined to judge)0.0000.000

Machine scores (provisional)

The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.

Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.

Opus teacher head0.033
GPT teacher head0.356
Teacher spread0.323 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Classification

machine, unvalidated

Machine predicted; a candidate call from one teacher head, not a consensus.

The models applied no category: nothing in the taxonomy fit this work.
Study designRandomized trial
Domainnot available
GenreEmpirical

How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".

Quick stats

Citations57
Published2024
Admission routes2
Has abstractyes

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