Evidence map›Paper›PMID 40775373›Full record

Trial reportAlzheimer's research & therapy2025

First-in-human study of neuron regenerative therapy NNI-362 to evaluate the safety, pharmacokinetics, and pharmacodynamics in healthy aged population.

Judith Kelleher-Andersson, Esther Yoon, Carol Green, Claire McFarlane, Donya Bagheri, Lynn Parker Thomas, R Scott Turner

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase I
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Alzheimer's research & therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04074837 (Phase1a, Randomized Placebo-controlled, Single and Multiple Dose, Dose-escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Oral NNI-362 in Healthy Aged Volunteers 50 to 72 Years of Age), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
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.

NCT04074837 phase1completednot on this map

Phase1a, Randomized Placebo-controlled, Single and Multiple Dose, Dose-escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Oral NNI-362 in Healthy Aged Volunteers 50 to 72 Years of Age

TypeinterventionalSponsorNeuronascent, Inc.Ran2019 to 2021Enrolled56ConditionsAlzheimer DiseaseArmsNNI-362, Placebo
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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.

Judith Kelleher-AnderssonDrug Development, NeuroNascent Inc, 6030 Day Break Circle, A150- PMB244, Clarksville, MD, 21029, USA. jkelleher@neuronascent.com.
Esther YoonCalifornia Clinical Trials Medical Group, 560 East Chevy Chase Drive, Glendale, CA, 91206, USA.
Carol GreenSRI International, 333 Ravenswood Avenue, Menlo Park, CA, 94025, USA.
Claire McFarlaneSRI International, 333 Ravenswood Avenue, Menlo Park, CA, 94025, USA.
Donya BagheriCCS Associates Inc, 2107 North First Street, Suite 640, San Jose, CA, 95131, USA.
Lynn Parker ThomasCCS Associates Inc, 2107 North First Street, Suite 640, San Jose, CA, 95131, USA.
R Scott TurnerDepartment of Neurology, Georgetown University, District of Columbia, Pasquerilla Healthcare Center, 7th Floor, 3800 Reservoir Road NW, Washington, 20007, USA.

Funding

Completion of Non-clinical long-term GLP safety and GMP manufacture for first-in-class neuron regenerative therapy, NNI-362 Phase 2 POC AD trialU01AG082687 · NIA · NEURONASCENT, INC. · PI KELLEHER-ANDERSSON, JUDITH A · 2023 to 2024
$4.5M
NIA NIH HHS U01 AG082687NIA NIH HHS U01AG082687 (PI-Kelleher-Andersson)
6 · The paper itself

Abstract

backgroundA placebo-controlled, double-blind Phase 1a trial examined the safety, tolerability, and pharmacokinetics of NNI-362 as well as the pharmacodynamic outcome of plasma phosphorylated tau

methodsOral NNI-362 and placebo were randomized in healthy, cognitively-unimpaired individuals (ages 50-72) at a 3:1 ratio, with sponsor, principal investigator, and subjects all blinded. Plasma levels of p-tau

resultsNNI-362 treatment was safe and well tolerated in older individuals. NNI-362, at the two highest multiple doses, significantly reduced plasma p-tau

conclusionsThese findings suggest in older subjects, oral NNI-362 appeared safe, well tolerated and reduced plasma p-tau TRIAL REGISTRY NUMBER: NCT04074837. First registered: 2019-08-27.

Indexed as

Nerve Regenerationtau ProteinsAgedBiomarkersDouble-Blind MethodFemaleHumansMaleMiddle AgedBiomarkerstau ProteinsAgingAlzheimer’s diseaseMultiple ascending doseNeuron regenerationPharmacodynamicsPharmacokineticsPlasma p-tau181SafetySingle ascending dose

Identifiers

PMID40775373
PMCPMC12330068

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Registered trials

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.