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

NCT02667496 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2017-04-07

No results posted yet for this study

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.

Conditions

  • Dementia Alzheimer's Type

Interventions

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

Sponsors & Collaborators

  • National Institute on Aging (NIA)

    collaborator NIH

  • Sanofi

    lead INDUSTRY

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2017-03-31
Completion
2017-03-31

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02667496 on ClinicalTrials.gov