A Phase 2 interventional study of IN insulin and Sterile Saline placebo in HIV Associated Neurocognitive Disorder (HAND), sponsored by University of Calgary. Terminated at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-06-11.
Sponsored by University of Calgary · Phase 2, Interventional, and Treatment
Among 26 studies in Neurocognitive Disorders with a site in Canada — 10 open to participants now, 13 under way, none of them phase 3. Neurocognitive Disorders · Canada.
Among the 26 studies in Neurocognitive Disorders with a site in Canada, this one is the 17th largest by enrollment of the 17 interventional ones that give a count, is one of 3 that started in 2018, is one of 5 in phase 2, and was the 4th registered.
274 studies on the registry are indexed under Neurocognitive Disorders; 90 are open to participants now.
Browse Neurocognitive Disorders studies →10 of the 26 studies in Neurocognitive Disorders with a site in Canada are open now. Recruiting first, the newest first:
St. Joseph's Healthcare Hamilton · Sites in Canada
Ages 60–90
MapLight Therapeutics · Sites in Canada, United States, Argentina and 12 more countries
Ages 55–90
Olivier Beauchet · Sites in Canada
Ages 65+
University of Manitoba · Sites in Canada, Spain, United Kingdom
Ages 6+ · Healthy volunteers
Laval University · Sites in Canada
Ages 65+
A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →
Of the 60 Neurocognitive Disorders studies recruiting now, 37 (62%) set no upper age limit and 2 (3%) stop at 75 or younger; 4 take children under 18; 17 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
26 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 2 6 · Phase 3 4 · Phase 4 1
First in 2014; this study’s year is marked. 3 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 4 is below the median of 80 across 175 interventional studies indexed under Neurocognitive Disorders.
Median enrollment 207 across the 17 interventional studies, 225 across the 9 observational. Of the 12 that completed or were terminated, 5 (42%) have results posted.
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7 of 26 have an industry lead sponsor. The 10 most frequent:
University of Calgary is the lead sponsor of 703 studies on the registry; 196 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 2 (20%) have results posted.
University of Calgary has 2 studies filed under Neurocognitive Disorders — fewer than ten, so there is no comparison to draw.
3 of the studies in Neurocognitive Disorders with a site in Canada that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05561205Sunnybrook Health Sciences CentrerTMS for Apathy Clinical Trial | 2026-12-01 |
| NCT07038798St. Joseph's Healthcare HamiltonDeep rTMS for Mild Neurocognitive Disorder in Older Adults | 2027-01 |
| NCT07714174Samuel Lunenfeld Research Institute, Mount Sinai HospitalPost-operative Cognitive Decline After Ambulatory Cataract Surgery in the Elderly Population | 2027-11-01 |
Add all 3 to your calendar (.ics) → With an account.
Among the 26 studies in Neurocognitive Disorders with a site in Canada, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
This study aims to see whether intranasal insulin is an effective treatment for problems with memory, concentration, slowed thinking, or any other cognitive function in people living with HIV/AIDS. This group of signs and symptoms are called 'HIV-associated neurocognitive disorders' or HAND. HAND can affect people living with HIV/AIDS even when they receive potent anti-HIV treatments. Treatment of HAND by specific medication or other means is not yet available. Intranasal insulin treatment has virtually no side-effects, and has already been tested in people with Alzheimer's disease, where it showed beneficial effects on memory, mood and quality of life
This study is designed as a prospective, double-blinded pilot study of intranasal (IN) insulin versus placebo in people with HAND (n = 20) on stable ART medication. Participants will be randomly assigned to one of two groups: 40 IU IN insulin R twice daily, or matched-volume placebo, which will be administered twice daily, taken after breakfast and again after dinner using a nasal delivery device. Serum glucose will be tested for hypoglycemia one hour after the initial administration of IN insulin or placebo and after administration at Weeks 1, 2, and 3. If the dose is tolerated and no side effects are reported the participant will continue in the study. If the dose is not tolerated due to hypoglycemia then the participant will be withdrawn from the study.
The objectives of this study are as follows:
Primary: Determine if IN insulin treatment administered twice daily for 4 months reduces overall neurocognitive deficits (based on the global z-score in people with HAND).
Secondary: Measure effects of IN insulin on individual neuropsychological domains (e.g., memory, processing speed, executive functions, motor functions) and on HAND disease progression; Define impacts of IN insulin on quality of life and mood in people with HAND; Investigate IN insulin's effects on HAND biomarker profiles in urine and blood.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: IN insulin Dosage form: intranasal Dose: 40 IU Frequency: bid Duration: 16 weeks
Biological: IN insulin
Drug: Sterile Saline Dosage form: intranasal Frequency: bid Duration: 16 weeks
Biological: Sterile Saline placebo
IN insulin twice daily taken after breakfast and again after dinner using the nasal delivery device.
Also known as: Intranasal Humulin R
Sterile Saline placebo twice daily taken after breakfast and again after dinner using the nasal delivery device.
Change in Global Neurocognitive Performance from Baseline
Change in overall neurocognitive function as measured by the global z score. The global z score is one measurement calculated as the average of z scores from each domain tested.
Time frame: 18 weeks
Change from Baseline in Neurocognitive Performance: Memory
Change from baseline in the overall z score for the memory domain, calculated as the average of z scores from: Hopkins Verbal Learning Test, Logical Memory Test, and Brief Visual Memory Test (immediate and delayed recall).
Time frame: 18 weeks
Change from Baseline in Neurocognitive Performance: Executive Function
Change from baseline in the overall z score for the executive function domain, calculated as the average of z scores from: D-KEFS Trail-making Task (Letter-Switching) and Color-Word Interference (Stroop).
Time frame: 18 weeks
Change from Baseline in Neurocognitive Performance: Attention
Change from baseline in the overall z score for the attention domain, calculated as the average of z scores from: Symbol Digit Modalities Test, D-KEFS Trail-making Test (Number), and Color-Word Interference (Color and Word Reading).
Time frame: 18 weeks
Change from Baseline in Neurocognitive Performance: Motor Function
Change from baseline in the overall z score for the motor function domain, calculated as the average of z scores from: grooved pegboard completion times for dominant and non-dominant hands.
Time frame: 18 weeks
Change from Baseline in Neurocognitive Performance: Language
Change from baseline in the overall z score for the language domain, calculated as the average of z scores from: D-KEFS Letter and Category Verbal Fluency Tasks
Time frame: 18 weeks
Change from baseline in HQoL questionnaire score
Change from baseline in health-related quality of life (HQoL) questionnaire score
Time frame: 18 weeks
Change from baseline in the PHQ-9 Questionnaire score
Change in the Patient Health Questionnaire-9 (PHQ-9) depressive symptoms score.
Time frame: 18 weeks
Change from Baseline in the Frailty Index Score - questionnaire and clinic assessment
Change in the overall Frailty Index score measured from baseline to Week 8.
Time frame: 16 weeks
Change from Baseline HAND inflammasome biomarker laboratory result profile
Change in inflammasome biomarker laboratory result profile between baseline and week 16.
Time frame: 16 weeks
Change from Baseline HAND metabolomics biomarker laboratory result profile
Change in metabolomics biomarker laboratory result profile between baseline and week 16.
Time frame: 16 weeks
Change from Baseline plasma HIV-1 viral load laboratory result
Change in plasma HIV-1 viral load between baseline and week 16.
Time frame: 16 weeks
Change from Baseline blood CD4 T-cell count laboratory result
Change in blood CD4 T-cell count between baseline and week 16.
Time frame: 16 weeks
Plan to share: No
Ran from Nov 2018 to primary completion in Apr 2019, 5 months.
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This study is terminated, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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