Trial · NCT04115384
Intranasal Insulin in Frontotemporal Dementia (FTD)
NCT04115384, Phase 2, Terminated, HealthPartners Institute; results first posted 2023-07-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Intranasal Insulin in Frontotemporal Dementia (FTD). Trials, record NCT04115384. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04115384
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Intranasal Insulin in Frontotemporal Dementia (FTD)
- NCT number
- NCT04115384
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 3 participants, actual
- Lead sponsor
- HealthPartners Institute
- Conditions
- Frontotemporal Dementia, Behavioral Variant
- Interventions
- Novolin-R insulin
- First posted
- 2019-10-04
- Last updated
- 2023-10-27
- Results first posted
- 2023-07-06
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Feasibility Measured by EXAMINER Battery | Baseline and Post Treatment | Number of patients completing the entire EXAMINER battery. Range: 0-3. More participants completing EXAMINER indicates higher feasibility. |
| Primary | Feasibility Measured by Recruitment | Baseline | Number of patients enrolled in this study. Range: 0-12. More participants enrolling indicates higher feasibility. |
| Primary | Safety Measured by Total Serious Adverse Events (SAEs) and Adverse Events (AEs) | 2 months | Total number of AEs/SAEs during the course of treatment. More AEs/SAEs indicates a less safe treatment. |
| Secondary | Feasibility Measured by Completion of Study | 2 months | Number of patients completing the entire study. Range: 0-12. More participants completing the study indicates higher feasibility. |
| Secondary | Feasibility Measured by Screen Fails | 2 years | Number of patients screen failing during the study. More participants screen failing the study indicates lower feasibility. |
| Secondary | Safety Measured by Unique Subjects With Serious Adverse Events (SAEs) and Adverse Events (AEs) | 4 weeks | Total number of unique participants experiencing AEs/SAEs during the course of treatment. More unique participants experiencing AEs/SAEs indicates a less safe treatment. |
| Other | Pre to Post Working Memory Measured by EXAMINER - Dot Counting | 4 weeks | Dot counting measures verbal working memory. Participants are asked to count colored shapes on a tables and remember the final total over 6 trials. Scores are totaled as the number of correct answers or the number of answers recalled. Range: 0-27. A higher score indicates better performance. |
| Other | Pre to Post Verbal Fluency Measured by EXAMINER - Animal Fluency | 4 weeks | Participants are asked to name as many animals as he/she can in 60 seconds. Scores are totaled as the number of animals verbalized. A higher score indicates better performance. |
| Other | Pre to Post Inhibition by EXAMINER - Flanker | 4 weeks | Participants are asked to choose the direction of one the center arrow in a group 5 arrows. Range: 0- 10. This is a global score that combines accuracy and reaction time. A higher score indicates better performance. |
| Other | Pre to Post Inhibition by EXAMINER - Set Shifting | 4 weeks | Participants are asked to match stimulus on different parts of a tablet screen. Range: 0- 10. This is a global score that combines accuracy and reaction time. A higher score indicates better performance. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Feasibility Measured by EXAMINER Battery | Baseline and Post Treatment | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Feasibility Measured by Recruitment | Baseline | The original goal was to include 12 participants. Since this is a feasibility outcome, the analysis population is the original goal total. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Safety Measured by Total Serious Adverse Events (SAEs) and Adverse Events (AEs) | 2 months | Total number of AEs/SAEs reported | NUMBER | |
| SECONDARY | Feasibility Measured by Completion of Study | 2 months | 12 participants were expected. Only 3 participants were able to complete the trial | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Feasibility Measured by Screen Fails | 2 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Safety Measured by Unique Subjects With Serious Adverse Events (SAEs) and Adverse Events (AEs) | 4 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Pre to Post Working Memory Measured by EXAMINER - Dot Counting | 4 weeks | score on a scale | MEAN | |
| OTHER_PRE_SPECIFIED | Pre to Post Verbal Fluency Measured by EXAMINER - Animal Fluency | 4 weeks | named animals | MEAN | |
| OTHER_PRE_SPECIFIED | Pre to Post Inhibition by EXAMINER - Flanker | 4 weeks | score on a scale | MEAN | |
| OTHER_PRE_SPECIFIED | Pre to Post Inhibition by EXAMINER - Set Shifting | 4 weeks | change is score on a scale | MEAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Feasibility Measured by EXAMINER Battery | Insulin (Novolin-R) | 3 | Participants | ||
| Feasibility Measured by Recruitment | Insulin (Novolin-R) | 3 | Participants | ||
| Safety Measured by Total Serious Adverse Events (SAEs) and Adverse Events (AEs) | Insulin (Novolin-R) | 1 | Total number of AEs/SAEs reported | ||
| Feasibility Measured by Completion of Study | Insulin (Novolin-R) | 3 | Participants | ||
| Feasibility Measured by Screen Fails | Insulin (Novolin-R) | 0 | Participants | ||
| Safety Measured by Unique Subjects With Serious Adverse Events (SAEs) and Adverse Events (AEs) | Insulin (Novolin-R) | 1 | Participants | ||
| Pre to Post Working Memory Measured by EXAMINER - Dot Counting | Insulin (Novolin-R) | 6.33 | Standard Deviation 3.06 | score on a scale | |
| Pre to Post Verbal Fluency Measured by EXAMINER - Animal Fluency | Insulin (Novolin-R) | -0.33 | Standard Deviation 3.21 | named animals | |
| Pre to Post Inhibition by EXAMINER - Flanker | Insulin (Novolin-R) | -0.145 | Standard Deviation 0.26 | score on a scale | |
| Pre to Post Inhibition by EXAMINER - Set Shifting | Insulin (Novolin-R) | -0.36 | Standard Deviation 0.13 | change is score on a scale |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Insulin (Novolin-R) | 3 | |
| Overall Study | COMPLETED | Insulin (Novolin-R) | 3 | |
| Overall Study | NOT COMPLETED | Insulin (Novolin-R) | 0 |
Source ClinicalTrials.gov
Adverse events1
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 | Coughing | Respiratory, thoracic and mediastinal disorders | Insulin (Novolin-R) | 1 | 3 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Insulin (Novolin-R) | 0 | 3 |
| Total, other adverse events | Insulin (Novolin-R) | 1 | 3 |
| Total, serious adverse events | Insulin (Novolin-R) | 0 | 3 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
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.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests2
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 |
|---|---|---|
| Category Fluency | Other outcome | ConductCognition |
| Verbal Fluency | Other 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/NCT04115384
GET https://conductscience.org/api/trials/v1/NCT04115384/registered