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Investigating Brain Insulin Resistance in Alzheimer Disease with IntraNasal Insulin : a Multimodal Neuroimaging Study

Investigating Brain Insulin Resistance in Alzheimer Disease with Intra-Nasal Insulin Administration: a Multimodal Neuroimaging Study

Asset

Insulin

Listed sites

0

Recruiting sites

-

Enrollment

-

actual

Study population

Alzheimer’s disease, MCI / preclinical Alzheimer’s

Key I/E criterion

•Alzheimer's disease

Primary endpoints

•Effects of INI administration on FMRI data in the 3 groups•Effects of INI administration on PET-FDG regional standardized data in the 3•Effects of INI administration on PET-FDG global data in the 3 groups

Identifiers

Registered as

Ctis2023-508203-20-00
NCT IDNCT06391853
Org study IDSRB2023-183

Timeline

Milestones

Study first posted2024-04-30actual
Study start2024-10-01estimated
Last update posted2025-01-27actual
Primary completion2026-03-01estimated
Study completion2026-10-01estimated

Assets

Drug assets

Insulin

Study populations

Who this study enrolls

Alzheimer’s diseaseMCI / preclinical Alzheimer’s

Eligibility

Who can enroll

Minimum age21 Years
Maximum age85 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

For the young subject group (group 1):

•Men and women aged 21-45 years old.
•Women under effective contraception.
•For Women, the study protocol should be performed during the follicular phase of the menstrual cycle, because of …
•Subjects must be proficient in speaking, reading and understanding French in order to be assessed with the neuropsychological tests battery.

For the MCI/AD group (group 2):

•Men and women aged 40-85 years old.
•Patients included on the registry of Neurodegeresence study in Hopital Erasme.
•Patients are capable of providing informed consent.
•Patients are proficient in speaking, reading and understanding French, in order to be assessed with the neuropsychological tests battery.
•Being diagnosed with amnestic MCI or probable mild AD, according to the core clinical criteria of the NIA and Alzheimer's Association guidelines.
•If the patient has a prescription medication acetylcholinesterase inhibitor (e.g. donepezil, rivastigmine, galantamine) and/or memantine doses has to be stable since 1 month at least.

For the group 2 - matched controls (group 3):

•Men and women aged 40-85 years old.
•Participants capable of providing informed consent
•Subjects are proficient in speaking, reading and understanding French, in order to be assessed with the neuropsychological tests battery

Exclusion criteria

Exclusion criteria related to trimodal neuroimaging data acquisition:

•Dense or tight hair braiding or scalp lesions, preventing adequate EEG cap positioning.
•Pregnancy and/or breastfeeding.
•Claustrophobia.
•Metallic component (e.g. pacemaker) incompatible with the MRI acquisition.
•Participants over 120 kg for radioprotection issues.

Exclusion criteria related to demographic data:

•Any acute medical condition that required either hospitalization or surgery within the past 6 months.
•The subject has participated in a clinical trial investigation within 1 month of this study.
•Current or past psychiatric illness (according to the Mini International Neuropsychiatric Interview [MINI])
•For healthy participants (groups 1 and 3), having a first degree relative with dementia onset before 65 years (Alzheimer, Lewy body disease, Parkinson)
•Dementia (Mini-Mental State Examination [MMSE] scores ≤ 20) for group 2 and 3.
•CDR score ≥2, witch will be evaluated before inclusion by investigator for group 2 and 3.
•Current recreational drug or alcohol abuse.
•Serious systemic disease that would interfere with the conduction of the trial .
•Based on selection of Dementia from neurologic causes, Hachinski Ischemia Score > 4 (55).

Exclusion criteria related to the use of INI as IMP:

•Being under corticosteroid treatment (non-topical treatment)
•Being under birth-control pill containing ethinyl estradiol.
•The subject has an allergy to the IMP.
•History of bleeding disorder.
•The use of anticoagulants warfarin (Coumadin) or dabigatran (Pradaxa)
•Taking a hormonal therapy (e.g., post menopausal, oncological treatment…)
•Type 1 DM or Type 2 DM treated with insulin.
•History of severe hypoglycaemia.
•Participant being under any chronic Intranasal treatment.

Criteria susceptible to postpone study inclusion:

•Clogged or runny nose.
•Current Ears Nose Throat (ENT) infection.
•Fever during the last 24 hours.
•Consumption of caffeine during the last 24 hours.
•Fasting period inferior to 12h before study visits.
•Sleep deficiency the night preceding study days as assessed by Pittsburgh Survey

Endpoints (15)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)
6
Memory
3
Executive function / language
3
Fluid / digital biomarkers
2
Neuroimaging
1

Memory

3 endpoints
Secondary/protocol endpoint

Impact of intranasal insulin administration on cognition and episodic memory

Time frame:end of acquisition for each group (each group of 30 subject estimated at 12 weeks after first subjet acquisition)

ratio, descriptive

Secondary/protocol endpoint

Impact of INI Administration on Spatial Memory

Time frame:end of acquisition for each group (each group of 30 subject estimated at 12 weeks after first subjet acquisition)

ratio, descriptive

Secondary/protocol endpoint

Impact of INI Administration on Global Memory Performance

Time frame:end of acquisition for each group (each group of 30 subject estimated at 12 weeks after first subjet acquisition)

ratio, descriptive

Executive function / language

3 endpoints
Secondary/protocol endpoint

Impact of intranasal insulin administration on attention / visual scanning

Time frame:end of acquisition for each group (each group of 30 subject estimated at 12 weeks after first subjet acquisition)

ratio, descriptive

Secondary/protocol endpoint

Impact of intranasal insulin administration on attention / mental flexibility

Time frame:end of acquisition for each group (each group of 30 subject estimated at 12 weeks after first subjet acquisition)

ratio, descriptive

Secondary/protocol endpoint

Impact of intranasal insulin administration on attention / inhibition.

Time frame:end of acquisition for each group (each group of 30 subject estimated at 12 weeks after first subjet acquisition)

ratio, descriptive

Neuroimaging

1 endpoint
Primary/protocol endpoint

Effects of INI administration on FMRI data in the 3 groups

Time frame:end of acquisition for each group (each group of 30 subject estimated at 12 weeks after first subjet acquisition)

percent change from baseline, improvement

Fluid / digital biomarkers

2 endpoints
Primary/protocol endpoint

Effects of INI administration on EEG connectivity data in the 3 groups

Time frame:end of acquisition for each group (each group of 30 subject estimated at 12 weeks after first subjet acquisition)

ratio, descriptive

Primary/protocol endpoint

Effects of INI administration on EEG Frequency band data in the 3 groups

Time frame:end of acquisition for each group (each group of 30 subject estimated at 12 weeks after first subjet acquisition)

event count, event

Other (unclassified)

6 endpoints
Primary/protocol endpoint/low confidence

Effects of INI administration on PET-FDG regional standardized data in the 3 groups

Time frame:end of acquisition for each group (each group of 30 subject estimated at 12 weeks after first subjet acquisition)

concentration, descriptive

Primary/protocol endpoint/low confidence

Effects of INI administration on PET-FDG global data in the 3 groups

Time frame:end of acquisition for each group (each group of 30 subject estimated at 12 weeks after first subjet acquisition)

ratio, descriptive

Secondary/protocol endpoint/low confidence

Impact of gender on Intranasal insulin administration responses

Time frame:end of acquisition for each group (each group of 30 subject estimated at 12 weeks after first subjet acquisition)

ratio, descriptive

Secondary/protocol endpoint/low confidence

Impact APOE (apolipoprotein E ) genetic status on Intranasal insulin administration responses

Time frame:end of acquisition for each group (each group of 30 subject estimated at 12 weeks after first subjet acquisition)

ratio, descriptive

Secondary/protocol endpoint/low confidence

Impact of Insulino-resistance scores ( Homeostatic Model Assessment of insulin resistance Scale (HOMA-IR) ), on Intranasal insulin administration responses

Time frame:end of acquisition for each group (each group of 30 subject estimated at 12 weeks after first subjet acquisition)

ratio, descriptive

Secondary/protocol endpoint/low confidence

Impact of INI Administration on Fluency

Time frame:end of acquisition for each group (each group of 30 subject estimated at 12 weeks after first subjet acquisition)

event count, event

Publications (16)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.