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WithdrawnPhase 2

SNIFF - 3-Week Aptar CPS Device

Study of Nasal Insulin to Fight Forgetfulness (SNIFF) - 3-Week Aptar CPS Device

Asset

Insulin

Listed sites

0

Recruiting sites

-

Enrollment

-

actual

Study population

Alzheimer’s disease, MCI / preclinical Alzheimer’s

Key I/E criteria

Alzheimer's diseaseAmyloid biomarker required (PET/CSF)

Primary endpoint

Percentage of Prescribed Dose Taken

Identifiers

Registered as

Org study IDIRB00073876
NCT IDNCT05006599

Timeline

Milestones

Study first posted2021-08-16actual
Study start2025-05estimated (month precision)
Last update posted2025-07-28actual
Primary completion2029-05estimated (month precision)
Study completion2031-05estimated (month precision)

Assets

Drug assets

Study populations

Who this study enrolls

Alzheimer’s diseaseMCI / preclinical Alzheimer’s

Eligibility

Who can enroll

Minimum age55 Years
Maximum age85 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

1. Age 55 to 85 (inclusive)

2. Fluent in English

3. Cognitively normal or diagnosis of amnestic mild cognitive impairment (aMCI) or mild Alzheimer's disease (AD)

4. Amyloid positive by positron emission tomography (PET) or cerebrospinal fluid (CSF) criteria

5. Stable medical condition for 3 months prior to screening visit

6. Stable medications for 4 weeks prior to the screening and study visits (exceptions may be made on a case by case basis by the study physician)

7. Clinical laboratory values must be within normal limits or, if abnormal, must be judged to be clinically insignificant by the study physician

Exclusion criteria

1. A diagnosis of dementia other than Alzheimer's disease (AD)

2. History of a clinically significant stroke

3. Current evidence or history in past two years of epilepsy, head injury with loss of consciousness, any major psychiatric disorder including psychosis, major depression, bipolar disorder

4. Diabetes (type I or type II) insulin-dependent and non-insulin-dependent diabetes mellitus

5. Current or past regular use of insulin or any other anti-diabetic medication within 2 months of screening visit

6. History of seizure within past five years

7. Pregnancy or possible pregnancy

8. Use of anticoagulants

9. Residence in a skilled nursing facility at screening

10. Use of an investigational agent within two months of screening visit

11. Regular use of alcohol, narcotics, anticonvulsants, anti-parkinsonian medications, or any other exclusionary medications (exceptions may be made on a case by case basis by the study physician)

Endpoints (14)

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

Global cognition
3
Behavior / neuropsychiatric
3
Fluid / digital biomarkers
3
Amyloid biomarkers
2
Function / daily living
1
Tau biomarkers
1
Other clinical outcomes
1

Global cognition

3 endpoints
Secondary/protocol endpoint

Change in the Preclinical Alzheimer Cognitive Composite 5 (PACC5) Z-Score

Time frame:Baseline to Week 8

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/protocol endpoint

Change in the 14-item Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog 14) Score

Time frame:Baseline to Week 8

ADAS-Cog

change from baseline, improvement

Other/protocol endpoint

Change in Quick Dementia Rating Scale (QDRS) Score

Time frame:Baseline to Week 8

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

change from baseline, improvement

Function / daily living

1 endpoint
Other/protocol endpoint

Change in the Alzheimer's Disease Cooperative Study Activities of Daily Living Scale for Mild Cognitive Impairment (ADCS-ADL-MCI)

Time frame:Baseline to Week 8

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Behavior / neuropsychiatric

3 endpoints
Other/protocol endpoint

Change in Patient Health Questionnaire (PHQ-9) Score

Time frame:Baseline to Week 8

change from baseline, improvement

Other/protocol endpoint

Change in Generalized Anxiety Disorder scale-7 (GAD-7) Score

Time frame:Baseline to Week 8

change from baseline, improvement

Other/protocol endpoint

Change in PROMIS Sleep Disturbance Questionnaire Score

Time frame:Baseline to Week 8

change from baseline, improvement

Amyloid biomarkers

2 endpoints
Secondary/protocol endpoint

Change in amyloid β-peptide (Aβ) 40 (Aβ40) in Cerebrospinal Fluid (CSF)

Time frame:Baseline to Week 8

change from baseline, improvement

Secondary/protocol endpoint

Change in amyloid β-peptide (Aβ) 42 (Aβ42) in Cerebrospinal Fluid (CSF)

Time frame:Baseline to Week 8

change from baseline, improvement

Tau biomarkers

1 endpoint
Secondary/protocol endpoint

Change in Cerebrospinal Fluid (CSF) Levels of Total Tau

Time frame:Baseline to Week 8

change from baseline, improvement

Fluid / digital biomarkers

3 endpoints
Secondary/protocol endpoint

Change in Cerebrospinal Fluid (CSF) Insulin Levels

Time frame:Baseline to Week 8

change from baseline, improvement

Secondary/protocol endpoint

Change in Cerebrospinal Fluid (CSF) Levels of Phospho-Tau 181

Time frame:Baseline to Week 8

change from baseline, improvement

Secondary/protocol endpoint

Change in Cerebrospinal Fluid (CSF) Levels of Phospho-Tau 217

Time frame:Baseline to Week 8

change from baseline, improvement

Other clinical outcomes

1 endpoint
Primary/protocol endpoint

Percentage of Prescribed Dose Taken

Time frame:Week 4

threshold achievement, improvement

Publications (52)

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.