Trial · NCT01767909
The Study of Nasal Insulin in the Fight Against Forgetfulness (SNIFF)
NCT01767909, Phase 2, Phase 3, Completed, University of Southern California; results first posted 2020-05-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. The Study of Nasal Insulin in the Fight Against Forgetfulness (SNIFF). Trials, record NCT01767909. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01767909
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Study of Nasal Insulin in the Fight Against Forgetfulness (SNIFF)
- NCT number
- NCT01767909
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 240 participants, actual
- Lead sponsor
- University of Southern California
- Conditions
- Amnestic Mild Cognitive Impairment, Alzheimer's Disease
- Interventions
- Insulin (Humulin® R U-100), Placebo
- First posted
- 2013-01-15
- Last updated
- 2024-11-20
- Results first posted
- 2020-05-18
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Global Measure of Cognition as Measured by the Alzheimer's Disease Assessment Scale-Cognitive 12 (ADAS-Cog12) | 12 months (blinded phase) followed by 6 months (open label phase) | The ADAS-Cog is a psychometric instrument that evaluates memory, attention, reasoning, language, orientation, and praxis. The ADAS-Cog12 version was used in this study which includes Delayed Word Recall - a measure of episodic memory. Scores from the original portion of the test range from 0 (best) to 70 (worse) and then number of items not recalled ranging from 0-10 is added for a maximum score of 80. A positive change indicates cognitive worsening. |
| Secondary | Change in Memory Composite as Measured by Story Recall (Immediate Paragraph Recall and Delayed Paragraph Recall) and Free and Cued Selective Reminding Test (FCSRT) | 12 months (blinded phase) followed by 6 months (open label phase) | Memory Composite is composed from Story Recall (both Immediate Paragraph Recall and Delayed Paragraph Recall) and the Free and Cued Selective Reminding Test (FCSRT). Each of the three component scores were normalized by subtracting the baseline sample mean, and dividing by the baseline sample standard deviation, to form three separately standardized z-scores with mean 0 and standard deviation 1. The three Z-scores were summed to form the memory composite. No other standardization was performed on the sum. If any of Immediate Paragraph Recall, Delayed Paragraph Recall and FCSRT is missing, the memory composite is missing. Higher scores indicate better performance. In this study the scores ranged from about -4.74 to 9.15 at baseline, and about -5.10 to 9.43 across all visits over 12 months. |
| Secondary | Change in Daily Functioning as Measured by the ADCS-MCI Activities of Daily Living (ADCS-ADL-MCI) | 12 months (blinded phase) and 6 months (open label phase) | The Alzheimer's Disease Cooperative Study - Activities of Daily Living Scale (ADCS-ADL) is an activities of daily living questionnaire aimed at detecting functional decline in people with Mild Cognitive Impairment (MCI). In a structured interview format, informants are queried as to whether participants attempted each item in the inventory during the prior 4 weeks and their level of performance. The questions focus predominantly on instrumental activities of daily living scales (e.g. shopping, preparing meals, using household appliances, keeping appointments, reading). The total score can range from 0-54. A higher score indicates greater functional ability. |
| Secondary | Change in Cognitive Deficit as Measured by Clinical Dementia Rating - Sum of Boxes (CDR-SB) | 12 months (blinded phase) followed by 6 months (open label phase) | The Clinical Dementia Rating - Sum of Boxes (CDR-SB) is administered as a structured interview with the participant and study partner, where impairment is scored in each of categories: memory, orientation, judgment and problem solving, community affairs, home and hobbies and personal care. Impairment is scored on a scale in which none = 0, questionable = 0.5, mild = 1, moderate = 2 and severe = 3. The 6 individual category ratings, or "box scores", are added together to give the CDR-Sum of Boxes which ranges from 0-18 with higher scores indicated more impairment. |
| Secondary | Change in Hippocampal and Entorhinal Atrophy as Measured by Magnetic Resonance Imaging (MRI) | Screen and Month 12 | MRI will be used to assess the effect of treatment on rate of hippocampal and entorhinal atrophy, and conduct exploratory analyses of other brain regions. Volume change was normalized to the participant's own intracranial volume to account for each participant's brain size. |
| Secondary | Change in CSF Biomarkers of AD | Baseline and Month 12 | Quantify Abeta and Tau biomarkers in CSF |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Global Measure of Cognition as Measured by the Alzheimer's Disease Assessment Scale-Cognitive 12 (ADAS-Cog12) | 12 months (blinded phase) followed by 6 months (open label phase) | Modified intent-To-Treat \[mITT\] population: All randomized participants in Impel Device with ADAS-Cog12 observed at baseline and at least one follow-up. | Modeled change score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Memory Composite as Measured by Story Recall (Immediate Paragraph Recall and Delayed Paragraph Recall) and Free and Cued Selective Reminding Test (FCSRT) | 12 months (blinded phase) followed by 6 months (open label phase) | modeled change score on a scale | LEAST_SQUARES_MEAN | |
| SECONDARY | Change in Daily Functioning as Measured by the ADCS-MCI Activities of Daily Living (ADCS-ADL-MCI) | 12 months (blinded phase) and 6 months (open label phase) | Modified intent-To-Treat \[mITT\] population: All randomized participants in Impel Device with ADCS-ADL-MCI observed at baseline and at least one follow-up. | modeled change score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Cognitive Deficit as Measured by Clinical Dementia Rating - Sum of Boxes (CDR-SB) | 12 months (blinded phase) followed by 6 months (open label phase) | Modified intent-To-Treat \[mITT\] population: All randomized participants in Impel Device with CDR-SB observed at screening and at least one follow-up. | Modeled change in test score | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Hippocampal and Entorhinal Atrophy as Measured by Magnetic Resonance Imaging (MRI) | Screen and Month 12 | Intent-To-Treat \[ITT\] population: All randomized participants in Impel Device. Follow-up visits include month 12 and early termination 1 (et1) visits. Percent change data is available for 3 subjects with et1 visit and 187 subjects with month 12 as follow-up. | % change in volume | MEAN |
| SECONDARY | Change in CSF Biomarkers of AD | Baseline and Month 12 | CSF collection was optional; only a subset of participants underwent the LP procedure | pg/ml | MEAN |
Source ClinicalTrials.gov
Results by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Global Measure of Cognition as Measured by the Alzheimer's Disease Assessment Scale-Cognitive 12 (ADAS-Cog12) | Insulin (Humulin® R U-100) | Blinded Phase (M12 change from Baseline) | 3.893 | Standard Error 0.643 | Modeled change score on a scale |
| Change in Global Measure of Cognition as Measured by the Alzheimer's Disease Assessment Scale-Cognitive 12 (ADAS-Cog12) | Placebo | Blinded Phase (M12 change from Baseline) | 3.867 | Standard Error 0.650 | Modeled change score on a scale |
| Change in Global Measure of Cognition as Measured by the Alzheimer's Disease Assessment Scale-Cognitive 12 (ADAS-Cog12) | Insulin (Humulin® R U-100) | Open Label Phase (M18 change from Baseline) | 7.091 | Standard Error 0.937 | Modeled change score on a scale |
| Change in Global Measure of Cognition as Measured by the Alzheimer's Disease Assessment Scale-Cognitive 12 (ADAS-Cog12) | Placebo | Open Label Phase (M18 change from Baseline) | 6.164 | Standard Error 0.942 | Modeled change score on a scale |
| Change in Memory Composite as Measured by Story Recall (Immediate Paragraph Recall and Delayed Paragraph Recall) and Free and Cued Selective Reminding Test (FCSRT) | Insulin (Humulin® R U-100) | Blinded Phase (M12 change from Baseline) | -0.496 | Standard Error 0.163 | modeled change score on a scale |
| Change in Memory Composite as Measured by Story Recall (Immediate Paragraph Recall and Delayed Paragraph Recall) and Free and Cued Selective Reminding Test (FCSRT) | Placebo | Blinded Phase (M12 change from Baseline) | -0.433 | Standard Error 0.162 | modeled change score on a scale |
| Change in Memory Composite as Measured by Story Recall (Immediate Paragraph Recall and Delayed Paragraph Recall) and Free and Cued Selective Reminding Test (FCSRT) | Insulin (Humulin® R U-100) | Open Label Phase (M18 change from Baseline) | -0.594 | Standard Error 0.183 | modeled change score on a scale |
| Change in Memory Composite as Measured by Story Recall (Immediate Paragraph Recall and Delayed Paragraph Recall) and Free and Cued Selective Reminding Test (FCSRT) | Placebo | Open Label Phase (M18 change from Baseline) | -0.802 | Standard Error 0.184 | modeled change score on a scale |
| Change in Daily Functioning as Measured by the ADCS-MCI Activities of Daily Living (ADCS-ADL-MCI) | Insulin (Humulin® R U-100) | Blinded Phase (M12 change from Baseline) | -3.63 | Standard Error 0.769 | modeled change score on a scale |
| Change in Daily Functioning as Measured by the ADCS-MCI Activities of Daily Living (ADCS-ADL-MCI) | Placebo | Blinded Phase (M12 change from Baseline) | -4.26 | Standard Error 0.779 | modeled change score on a scale |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Insulin (Humulin® R U-100) | 121 | |
| Overall Study | STARTED | Placebo | 119 | |
| Overall Study | COMPLETED | Insulin (Humulin® R U-100) | 108 | |
| Overall Study | COMPLETED | Placebo | 107 | |
| Overall Study | NOT COMPLETED | Insulin (Humulin® R U-100) | 13 | |
| Overall Study | NOT COMPLETED | Placebo | 12 |
Source ClinicalTrials.gov
Adverse events68
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | BLOOD AND LYMPHATIC SYSTEM DISORDERS | Blood and lymphatic system disorders | Insulin (Humulin® R U-100) | 4 | 121 | 4 |
| other | BLOOD AND LYMPHATIC SYSTEM DISORDERS | Blood and lymphatic system disorders | Placebo | 2 | 119 | 2 |
| other | CARDIAC DISORDERS | Cardiac disorders | Insulin (Humulin® R U-100) | 8 | 121 | 9 |
| other | CARDIAC DISORDERS | Cardiac disorders | Placebo | 6 | 119 | 8 |
| other | DEMENTIA AND AMNESTIC CONDITIONS | Nervous system disorders | Insulin (Humulin® R U-100) | 0 | 121 | 0 |
| other | DEMENTIA AND AMNESTIC CONDITIONS | Nervous system disorders | Placebo | 1 | 119 | 1 |
| other | ENDOCRINE DISORDERS | Endocrine disorders | Insulin (Humulin® R U-100) | 1 | 121 | 1 |
| other | ENDOCRINE DISORDERS | Endocrine disorders | Placebo | 0 | 119 | 0 |
| other | EYE DISORDERS | Eye disorders | Insulin (Humulin® R U-100) | 5 | 121 | 5 |
| other | EYE DISORDERS | Eye disorders | Placebo | 2 | 119 | 2 |
1 to 10 of 68Source ClinicalTrials.gov
See all 68 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Insulin (Humulin® R U-100) | 1 | 121 |
| Total, all-cause mortality | Placebo | 0 | 119 |
| Total, other adverse events | Insulin (Humulin® R U-100) | 98 | 121 |
| Total, other adverse events | Placebo | 91 | 119 |
| Total, serious adverse events | Insulin (Humulin® R U-100) | 18 | 121 |
| Total, serious adverse events | Placebo | 10 | 119 |
Source ClinicalTrials.gov
Papers8
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| RF1AG041845 | Therapeutic Effect of Intranasal Insulin on Cognition, Function, and AD Biomarker | CRAFT, SUZANNE | WAKE FOREST UNIVERSITY HEALTH SCIENCES | NATIONAL INSTITUTE ON AGING | 2012 to 2017 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Insulin (Humulin® R U-100) vs Placebo: deaths from any cause | Trial comparisons |
| Insulin (Humulin® R U-100) vs Placebo: serious adverse events | Trial comparisons |
Tests3
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Delayed Recall Module | Primary outcome | ConductCognition |
| Selective Reminding Task | Secondary outcome | ConductCognition |
| Short Story Recall | Secondary outcome | ConductCognition |
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01767909
GET https://conductscience.org/api/trials/v1/NCT01767909/results?page=2