Intranasal oxytocin for apathy in people with frontotemporal dementia (FOXY): a multicentre, randomised, double-blind, placebo-controlled, adaptive, crossover, phase 2a/2b superiority trial.

Coleman KKL, Berry S, Cummings J, Hsiung GR, Laforce R, Huey E, Ducharme S, Tartaglia MC, Mendez MF, Onyike C, Domoto-Reilly K, Masellis M and 15 more

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Herrmann N, Porsteinsson A, Detry MA, Stewart C, Bosse AL, McGlothlin A, Dias B, Pandey S, Mayich M, Pasternak SH, Ruiz Garcia R, Restrepo-Martinez M, Feldman H, Boxer AL, Finger EC

The Lancet. Neurology1 Feb 2025Cited by 15 (Europe PMC)

PMID39862881PMCIDPMC13557230DOI10.1016/s1474-4422(24)00456-3PepBankPUB-39862881

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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study5

5 results from studies that gave the peptide. 5 results from people.

01HumanRandomized controlled trialEfficacy outcome
In people with frontotemporal dementia, intranasal oxytocin 72 IU every third day lowered the Neuropsychiatric Inventory apathy score by an estimated 1·32 points relative to placebo.
In plain wordsIn people with frontotemporal dementia, oxytocin nose spray every third day lowered apathy scores a little more than placebo did.
Peptide
Oxytocin
Outcome
DecreaseChange in Neuropsychiatric Inventory apathy score, oxytocin every third day versus placebo
Study
n: not reported in source
Comparator
Placebo
Analysis
Primary
Outcome group
Anxiety and mood · Nervous system and cognition
Studied dose
72 IU every third day · intranasal · 6 weeksAs given in this study (human).
Measurements
NPI apathy score difference vs placebo
−1.32 points
oxytocin every third day
Source sentences
Summary
Treatment with oxytocin every third day resulted in an improved Neuropsychiatric Inventory apathy score, with an estimated -1·32 points (95% CI -2·43 to -0·21) relative to placebo (one sided p=0·010)
2 context sentences(design, population, supporting numbers)
Summary · context
The primary outcome was difference in the change in Neuropsychiatric Inventory apathy scores for oxytocin versus placebo periods in the per-protocol population after 6 weeks of treatment.
Summary · context
In stage 1, participants were randomly assigned (1:1:1:1:1:1) to one of three dose schedules (every day, every other day, and every third day) of 72 IU intranasal oxytocin or placebo and to the order they would received the intervention in the crossover; intranasal oxytocin or placebo were administe…
Report a problemFND-3986288101
02HumanRandomized controlled trialOther
In stage 1 of the trial in people with frontotemporal dementia, 72 IU oxytocin every third day was the optimal dose schedule by Bayesian posterior probability (Pr(Best)=0·478).
In plain wordsIn people with frontotemporal dementia, the trial found that 72 IU of oxytocin every third day was the best of the three dosing schedules tested.
Peptide
Oxytocin
Outcome
Not applicableOptimal dose schedule in stage 1
Study
n = 60
Comparator
Placebo
Outcome group
Anxiety and mood · Nervous system and cognition
Studied dose
72 IU every third day · intranasal · 6 weeksAs given in this study (human).
Source sentences
Summary
72 IU oxytocin every third day was the optimal dose schedule from stage 1 based on its Bayesian posterior probability (Pr(Best)=0·478).
1 context sentence(design, population, supporting numbers)
Summary · context
In stage 1, participants were randomly assigned (1:1:1:1:1:1) to one of three dose schedules (every day, every other day, and every third day) of 72 IU intranasal oxytocin or placebo and to the order they would received the intervention in the crossover; intranasal oxytocin or placebo were administe…
Report a problemFND-3986288102
03HumanRandomized controlled trialSafety outcome
In people with frontotemporal dementia, upper respiratory tract infection occurred in five (6%) of 78 participants on placebo and in three (5%) on oxytocin every third day.
In plain wordsIn people with frontotemporal dementia, upper respiratory infections were about as common with oxytocin every third day as with placebo.
Peptide
Oxytocin
Outcome
Not applicableUpper respiratory tract infection
Study
n: not reported in source
Comparator
Placebo
Outcome group
Adverse events · Whole body
Studied dose
72 IU · intranasal · 6 weeksAs given in this study (human).
Source sentences
Summary
Two adverse events were reported in at least 5% of participants: upper respiratory tract infection (five [6%] of 78 participants on placebo and three [5%] on every third day at all doses of oxytocin) and headache (two [3%] participants on placebo, one [7%] of 15 participants on oxytocin every day, a…
1 context sentence(design, population, supporting numbers)
Summary · context
In stage 1, participants were randomly assigned (1:1:1:1:1:1) to one of three dose schedules (every day, every other day, and every third day) of 72 IU intranasal oxytocin or placebo and to the order they would received the intervention in the crossover; intranasal oxytocin or placebo were administe…
Report a problemFND-3986288103
04HumanRandomized controlled trialSafety outcome
In people with frontotemporal dementia, headache occurred in two (3%) on placebo, one (7%) of 15 on oxytocin every day, and two (4%) of 55 on oxytocin every third day.
In plain wordsIn people with frontotemporal dementia, headache was reported by a few people on placebo and on oxytocin at each dose schedule.
Peptide
Oxytocin
Outcome
Not applicableHeadache
Study
n: not reported in source
Comparator
Placebo
Outcome group
Adverse events · Nervous system and cognition
Studied dose
72 IU · intranasal · 6 weeksAs given in this study (human).
Source sentences
Summary
Two adverse events were reported in at least 5% of participants: upper respiratory tract infection (five [6%] of 78 participants on placebo and three [5%] on every third day at all doses of oxytocin) and headache (two [3%] participants on placebo, one [7%] of 15 participants on oxytocin every day, a…
1 context sentence(design, population, supporting numbers)
Summary · context
In stage 1, participants were randomly assigned (1:1:1:1:1:1) to one of three dose schedules (every day, every other day, and every third day) of 72 IU intranasal oxytocin or placebo and to the order they would received the intervention in the crossover; intranasal oxytocin or placebo were administe…
Report a problemFND-3986288104
05HumanRandomized controlled trialSafety outcome
In people with frontotemporal dementia, no adverse events were attributed to oxytocin treatment.
In plain wordsIn people with frontotemporal dementia, no side effects were linked to oxytocin treatment.
Peptide
Oxytocin
Outcome
No significant changeAdverse events attributed to oxytocin
Study
n: not reported in source
Comparator
Placebo
Outcome group
Adverse events · Whole body
Studied dose
72 IU · intranasal · 6 weeksAs given in this study (human).
Source sentences
Summary
No adverse events were attributed to oxytocin treatment.
1 context sentence(design, population, supporting numbers)
Summary · context
In stage 1, participants were randomly assigned (1:1:1:1:1:1) to one of three dose schedules (every day, every other day, and every third day) of 72 IU intranasal oxytocin or placebo and to the order they would received the intervention in the crossover; intranasal oxytocin or placebo were administe…
Report a problemFND-3986288105

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · source ClinicalTrials.gov (opens in a new tab)

Status unknownPhase 2NCT03260920

Intranasal Oxytocin for Frontotemporal Dementia

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sn = 11231 Jan 2018 to est. 31 Dec 2024

Frontotemporal Dementia

Trial page ClinicalTrials.govUpdated 15 Dec 2023

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
11 Oct 2026, 00:50 UTC
Study results updated
Version 1
9 Oct 2026, 02:47 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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