Trial · NCT02064166
Treatment of Parkinson Disease and Multiple System Atrophy Using Intranasal Insulin.
NCT02064166, Phase 2, Completed, Peter Novak; results first posted 2018-11-23
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Treatment of Parkinson Disease and Multiple System Atrophy Using Intranasal Insulin. Trials, record NCT02064166. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02064166
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Treatment of Parkinson Disease and Multiple System Atrophy Using Intranasal Insulin.
- NCT number
- NCT02064166
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 15 participants, actual
- Lead sponsor
- Peter Novak
- Conditions
- Parkinson Disease, Multiple System Atrophy
- Interventions
- Intranasal Insulin
- First posted
- 2014-02-17
- Last updated
- 2018-11-23
- Results first posted
- 2018-11-23
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Verbal Fluency FAS (F, A or S Words) Total Score | Baseline and post-treatment | Changes in Verbal Fluency FAS (a total number of F, A or S words) generated after 4 weeks of treatment compared to baseline, FAS total score is a sum of F,A, and S raw scores. The verbal fluency FAS test is used to assess phonemic fluency and verbal memory. Participants are asked to name words starting with letters F, A and S over one minute interval. The unit is a on scale, the normative data are adjusted for age and sex. The higher score means better verbal fluency. |
| Secondary | Modified Hoehn and Yahr Scale | Baseline and post-treatment | The modified Hoehn and Yahr Scale (HY) is used to assess severity of Parkinson Disease and treatment response post treatment as compared to baseline. The scale ranges from 1 to 5. The lower score indicates better outcome, e.g. less severe parkinsonism. |
| Secondary | Cognitive Impairment Using Montreal Cognitive Assessment (MoCA) | Baseline and post-treatment | The Montreal Cognitive Assessment (MoCA) is a one-page 30-point test administered in approximately 10 minutes and is used to assess symptoms of cognitive impairment and their changes after treatment as compared to baseline. MoCA scores range between 0 and 30 with higher scores indicative of better cognitive performance. A score of 26 and above is considered to be normal. |
| Secondary | Beck Depression Inventory Score (BDI) | Baseline and post-treatment | Beck Depression Inventory (BDI) is a 21-items self reported inventory with a scale evaluating depressive symptoms and the changes in BDI after treatment compared to baseline. The range of scores is 0 to 63, with higher scores indicating greater severity of depression. |
| Other | Unified Parkinson's Disease Rating Scale Part III (UPDRS Part III) | Baseline and post-treatment | UPDRS Part III has 14 items assessing motor skills including facial expression and speech, tremors, rigidity, posture, gait, and bradykinesia. Left and right sides (arms, legs, and hands) are assessed separately for seven of the functions. The total score for subscale 3 ranges from 0 to 108 (the sum of scores from 14 items with 27 observations). The higher the value, the more severe the symptoms. The outcomes reflect the UPDRS Part III score at baseline and 4 weeks post treatment with post treatment scores compared to baseline in the insulin and placebo groups. |
| Other | Gait Analysis (4-meter Test) | Baseline and post-treatment | Changes in gait compared to baseline. Data are reported as changes in average stride interval ( inch) at baseline and post treatment. |
| Other | Brief Visuospatial Memory Test-Revised (BVMT-R) | Baseline and post-treatment | Changes in Brief Visuospatial Memory Test-Revised (BMVT-R) compared to baseline. For BVMT, there were concerns about the test administration and validity of this test which relies on fine motor control in PD patients that have motor impairment which could affect the drawing precision. Therefore, BVMT was not included in the analyses, because these methodological concerns would have affected the calculation of the total score as the outcome measure. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Verbal Fluency FAS (F, A or S Words) Total Score | Baseline and post-treatment | Words | MEAN | |
| SECONDARY | Modified Hoehn and Yahr Scale | Baseline and post-treatment | score on a scale | MEAN | |
| SECONDARY | Cognitive Impairment Using Montreal Cognitive Assessment (MoCA) | Baseline and post-treatment | score on a scale | MEAN | |
| SECONDARY | Beck Depression Inventory Score (BDI) | Baseline and post-treatment | score on a scale | MEAN | |
| OTHER_PRE_SPECIFIED | Unified Parkinson's Disease Rating Scale Part III (UPDRS Part III) | Baseline and post-treatment | score on a scale | MEAN | |
| OTHER_PRE_SPECIFIED | Gait Analysis (4-meter Test) | Baseline and post-treatment | inch | MEAN | |
| OTHER_PRE_SPECIFIED | Brief Visuospatial Memory Test-Revised (BVMT-R) | Baseline and post-treatment |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Verbal Fluency FAS (F, A or S Words) Total Score | Insulin Baseline | 38.8 | Standard Deviation 5.7 | Words | |
| Change in Verbal Fluency FAS (F, A or S Words) Total Score | Insulin Post Treatment | 41.0 | Standard Deviation 8.2 | Words | |
| Change in Verbal Fluency FAS (F, A or S Words) Total Score | Placebo Baseline | 32.8 | Standard Deviation 2.3 | Words | |
| Change in Verbal Fluency FAS (F, A or S Words) Total Score | Placebo Post Treatment | 30.8 | Standard Deviation 7.1 | Words | |
| Modified Hoehn and Yahr Scale | Insulin Baseline | 2.0 | Standard Deviation 0.6 | score on a scale | |
| Modified Hoehn and Yahr Scale | Insulin Post Treatment | 2.0 | Standard Deviation 0.7 | score on a scale | |
| Modified Hoehn and Yahr Scale | Placebo Baseline | 2.4 | Standard Deviation 0.38 | score on a scale | |
| Modified Hoehn and Yahr Scale | Placebo Post Treatment | 2.4 | Standard Deviation 0.2 | score on a scale | |
| Cognitive Impairment Using Montreal Cognitive Assessment (MoCA) | Insulin Baseline | 28.7 | Standard Deviation 1.2 | score on a scale | |
| Cognitive Impairment Using Montreal Cognitive Assessment (MoCA) | Insulin Post Treatment | 28.0 | Standard Deviation 1.1 | score on a scale |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 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 | 9 | |
| Overall Study | STARTED | Placebo | 6 | |
| Overall Study | COMPLETED | Insulin | 8 | |
| Overall Study | COMPLETED | Placebo | 6 | |
| Overall Study | NOT COMPLETED | Insulin | 1 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events2
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 | Pneumonia | Respiratory, thoracic and mediastinal disorders | Insulin | 1 | 9 | 1 |
| other | Pneumonia | Respiratory, thoracic and mediastinal disorders | Placebo | 0 | 6 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Insulin | 0 | 9 |
| Total, all-cause mortality | Placebo | 0 | 6 |
| Total, other adverse events | Insulin | 1 | 9 |
| Total, other adverse events | Placebo | 0 | 6 |
| Total, serious adverse events | Insulin | 0 | 9 |
| Total, serious adverse events | Placebo | 0 | 6 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31022213 | DERIVED |
Source PubMed
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Insulin vs Placebo: deaths from any cause | Trial comparisons |
| Insulin vs Placebo: serious adverse events | Trial comparisons |
Tests1
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 |
|---|---|
| Verbal Fluency | Primary outcome |
Source 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/NCT02064166
GET https://conductscience.org/api/trials/v1/NCT02064166/results?page=2