Safety Study of Sargramostim in Treating Patients With Mild Cognitive Impairment Due to Alzheimer's Disease

Phase 2

Withdrawn

• Conditions: Dementia Alzheimer's Type
• Interventions: Drug: Sargramostim GZ402664; Drug: Placebo; Drug: Florbetapir F18

• Registration Number: NCT02667496
• Lead Sponsor: Sanofi

Brief 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.

Study Timeline

• Study First Submitted: 2016-01-26
• Study First Submitted QC: 2016-01-28
• Study First Posted: 2016-01-29
• Study Start: 2016-11
• Primary Completion: 2017-03-31
• Study Completion: 2017-03-31
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-05
• Last Update Posted: 2017-04-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Leukine	Sargramostim GZ402664	Administered SC in treatment cycles up to 24 weeks Florbetapir administered for PET scans to examine baseline brain imaging pathology and changes on treatment.
Leukine	Florbetapir F18	Administered SC in treatment cycles up to 24 weeks Florbetapir administered for PET scans to examine baseline brain imaging pathology and changes on treatment.
Placebo	Placebo	Administered SC in treatment cycles up to 24 weeks Florbetapir administered for PET scans to examine baseline brain imaging pathology and changes on treatment.
Placebo	Florbetapir F18	Administered SC in treatment cycles up to 24 weeks Florbetapir administered for PET scans to examine baseline brain imaging pathology and changes on treatment.

Primary Outcome Measures

Name	Time	Method
Change from baseline in standardized uptake value ratio as measured by PET using florbetapir F18 (Amyvid)	From baseline to Week 24

Secondary Outcome Measures

Name	Time	Method
Number of patients experiencing treatment-emergent adverse events (TEAEs)	Week 24
Change from baseline in CSF analysis	Prior to first injection on Day 1 to serve as a baseline for any necessary follow-up, and optional assessment at Day 155
Measurement of antidrug antibody levels	At Days 1, 29, 57, 85, and 155
MRI to assess for emergence of amyloid related imaging abnormalities (ARIA)	At Screening and Days 43, 85, and 155

Trial Locations

Locations (1)

Investigational Site Number 840001; 🇺🇸 Houston, Texas, United States