Trials / Withdrawn
WithdrawnNCT02667496
Safety Study of Sargramostim in Treating Patients With Mild Cognitive Impairment Due to Alzheimer's Disease
A Study Examining the Safety and Activity of Innate Immune System Stimulation With Leukine® (Sargramostim) to Reduce Brain Amyloid Load in Patients With Mild Cognitive Impairment Due to Alzheimer's Disease
- Status
- Withdrawn
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- 40 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
Primary Objective: To compare the effect of repeat doses of Leukine to placebo administered subcutaneously (SC) on established cortical amyloid load in patients with mild cognitive impairment (MCI) due to Alzheimer's disease (AD). Secondary Objective: * To evaluate safety and tolerability of Leukine versus placebo. * To explore the effect of Leukine versus placebo on cognitive performance. * To collect biospecimens for future biomarker research.
Detailed description
The total duration of study period per patient is up to 28 weeks.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Sargramostim GZ402664 | Pharmaceutical form:solution Route of administration: subcutaneous |
| DRUG | Placebo | Pharmaceutical form:solution Route of administration: subcutaneous |
| DRUG | Florbetapir F18 | Pharmaceutical form:solution Route of administration: intravenous |
Timeline
- Start date
- 2016-11-01
- Primary completion
- 2017-03-31
- Completion
- 2017-03-31
- First posted
- 2016-01-29
- Last updated
- 2017-04-07
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02667496. Inclusion in this directory is not an endorsement.