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Fas3.4

Fasoracetam Research

Mostly mechanism / observationalLimited safety

5 peer-reviewed studies

What the evidence says

Mostly mechanism / observational

Most Fasoracetam studies are mechanism or observational rather than RCTs that measure a clinical effect — keep findings provisional.

Most evidence is from mixed-quality studies published 1997–2019 with a typical study size of 30 participants.

Based on 5 studies · 30 total participants

Confidence

Low

By outcome

ADHD & attention (mutation-selected)
Mostly mechanism / observational3 studies
Cognition (preclinical)
Mostly mechanism / observational3 studies

By the numbers

Pulled from 5 studies with measurable effects

Likely real effects

100%

across studies

People studied

typical study: 30 people

Strongest designs

0 pooled, 0 randomised

How long studies ran

1–4 weeks

Populations Studied

ADHD patients across trials1

Adolescents (12–17) with ADHD and mGluR-network gene mutations1

Rats (cholinergic-dysfunction models)1

Rats1

Older research base

Newest study from 2019

199720082019

1Efficacy of novel non-stimulant compounds for ADHDSystematic Review2019

A systematic review of randomised controlled trials assessing novel (non-stimulant) compounds for ADHD.

Nageye F, Cortese S · Expert review of neurotherapeutics (2019)

Systematic review of trials of novel, non-stimulant compounds for ADHD, including glutamatergic agents
Places fasoracetam among early, preliminary candidates rather than established treatments
Contextualizes the fasoracetam ADHD evidence as preliminary and in need of larger controlled trials

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2ADHD symptom severity (CGI-I / CGI-S)Open-Labeln=30 · small study2018

NFC-1 treatment resulted in significant improvement... Mean Clinical Global Impressions-Improvement and Severity scores improved from baseline to week 5 (P < 0.001).

Elia J, Ungal G, Kao C, Ambrosini A, et al. · Nature communications (2018)

Likely real

5-week, open-label, single-blind, placebo-controlled study of fasoracetam (NFC-1) in 30 adolescents aged 12–17 with ADHD harboring mutations in mGluR-network genes
Single-dose pharmacokinetic profiling from 50–800 mg, then symptom-driven dose advancement up to 400 mg twice daily for 4 weeks
Significant improvement on clinician-rated CGI-Improvement and CGI-Severity scales (P < 0.001)

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3Reversal of memory disruptionAnimal1999

NS-105 showed antiamnestic actions in a variety of animal models of cholinergic dysfunction employed in this study.

Ogasawara T, Itoh Y, Tamura M, Mushiroi T · Pharmacology, biochemistry, and behavior (1999)

Fasoracetam (NS-105) reversed memory disruption across scopolamine, nucleus-basalis-lesion, AF64A, baclofen, ischemia, and electroconvulsive-shock models in rats
Increased in vivo cortical acetylcholine release and high-affinity choline uptake
Antiamnestic effect spanned multiple cholinergic-dysfunction models

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4GABA-B receptor up-regulation and antidepressant-like behaviorAnimal1997

Repeated administration of NS-105 increased the number of GABA(B) receptors in rat cerebral cortex.

Shimidzu T, Itoh Y, Oka M, Ishima T · European journal of pharmacology (1997)

Repeated fasoracetam (NS-105) dosing increased GABA-B receptor number in rat cerebral cortex
Reduced immobility in the forced-swim test and reversed learned helplessness in the shuttle-box test
Did not inhibit monoamine uptake — distinct from classic antidepressants

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5mGluR-dependent modulation of adenylyl cyclase activityAnimal1997

Both the inhibitory and facilitatory actions of NS-105 on cAMP formation were mimicked by a metabotropic glutamate receptor agonist and blocked by a mGluR antagonist.

Oka M, Itoh Y, Shimidzu T, Ukai Y · Brain research (1997)

Fasoracetam (NS-105) modulated cAMP formation in rat cerebral cortex via metabotropic glutamate (mGluR) signaling
Effects were mimicked by an mGluR agonist and blocked by an mGluR antagonist, but not by an alpha2-adrenergic antagonist
Establishes mGluR as a core molecular target — the rationale later used for mutation-selected ADHD

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View in Research Library

Fasoracetam Research

Mostly mechanism / observational

By the numbers

Beyond stimulants: a systematic review of randomised controlled trials assessing novel compounds for ADHD.

Fasoracetam in adolescents with ADHD and glutamatergic gene network variants disrupting mGluR neurotransmitter signaling.

Involvement of cholinergic and GABAergic systems in the reversal of memory disruption by NS-105, a cognition enhancer.

Effect of a novel cognition enhancer NS-105 on learned helplessness in rats: possible involvement of GABA(B) receptor up-regulation after repeated treatment.

Involvement of metabotropic glutamate receptors in Gi- and Gs-dependent modulation of adenylate cyclase activity induced by a novel cognition enhancer NS-105 in rat brain.