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SNIFF - 3-Week Aptar CPS Device
Study of Nasal Insulin to Fight Forgetfulness (SNIFF) - 3-Week Aptar CPS Device
Lead sponsor
Asset
Insulin
Listed sites
0
Recruiting sites
-
Enrollment
-
actual
Study population
Alzheimer’s disease, MCI / preclinical Alzheimer’s
Key I/E criteria
•Alzheimer's disease•Amyloid biomarker required (PET/CSF)
Primary endpoint
•Percentage of Prescribed Dose Taken
Identifiers
Registered as
Timeline
Milestones
Assets
Drug assets
Study populations
Who this study enrolls
Eligibility
Who can enroll
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 endpointsChange 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
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
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 endpointChange 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 endpointsChange in Patient Health Questionnaire (PHQ-9) Score
Time frame:Baseline to Week 8
change from baseline, improvement
Change in Generalized Anxiety Disorder scale-7 (GAD-7) Score
Time frame:Baseline to Week 8
change from baseline, improvement
Change in PROMIS Sleep Disturbance Questionnaire Score
Time frame:Baseline to Week 8
change from baseline, improvement
Amyloid biomarkers
2 endpointsChange in amyloid β-peptide (Aβ) 40 (Aβ40) in Cerebrospinal Fluid (CSF)
Time frame:Baseline to Week 8
change from baseline, improvement
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 endpointChange in Cerebrospinal Fluid (CSF) Levels of Total Tau
Time frame:Baseline to Week 8
change from baseline, improvement
Fluid / digital biomarkers
3 endpointsChange in Cerebrospinal Fluid (CSF) Insulin Levels
Time frame:Baseline to Week 8
change from baseline, improvement
Change in Cerebrospinal Fluid (CSF) Levels of Phospho-Tau 181
Time frame:Baseline to Week 8
change from baseline, improvement
Change in Cerebrospinal Fluid (CSF) Levels of Phospho-Tau 217
Time frame:Baseline to Week 8
change from baseline, improvement
Other clinical outcomes
1 endpointPercentage 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
- PMID21514249via BACKGROUND
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- PMID10078556via BACKGROUND
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- PMID8071705via BACKGROUND
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- PMID6800439via BACKGROUND
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- PMID15262337via BACKGROUND
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- PMID1400644via BACKGROUND
- PMID15590928via BACKGROUND
- PMID19026743via BACKGROUND
- PMID22250775via BACKGROUND
- PMID11556941via BACKGROUND
- PMID16717171via BACKGROUND
Provenance
Sources
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.