Phase II Trial to Evaluate Safety and Efficacy of GM-CSF/Sargramostim in Alzheimer's Disease (SESAD)

Who is this study for? Patients with Alzheimer's disease
What treatments are being studied? Sargramostim
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

A medicine that is FDA-approved for bone marrow stimulation (called sargramostim) will be tested for its safety and efficacy in individuals with mild-to-moderate Alzheimer's disease over a six month treatment period.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Maximum Age: 85
Healthy Volunteers: f
View:

• Males or females between age 60 and 85 years, inclusive, at time of consent.

• Have a dedicated partner/caregiver informant who is in the company of the participant at least 12 hours a week, who can accompany them to scheduled visits, and who is able to provide accurate reporting upon the behavioral, cognitive and functional abilities of the participant.

• Be physically able to participate with adequate visual acuity and auditory discrimination.

• Be willing / able to provide written informed consent or assent.

• Must reside within a proximity of the study site that will not preclude their regularly-scheduled participation in the trial, as well as a catchment area for local lab blood draws (i.e. central contracted laboratory).

• Meet criteria for probable AD dementia according to the National Institute of Aging - Alzheimer's Association (NIA-AA) 2018 core research criteria, and have the following at screening:

‣ A diagnosis of mild AD or moderate AD, or

⁃ A provisional research diagnosis consistent with probable mild AD or moderate AD, and

⁃ MoCA score of 4-24 inclusive.

• Have positive biomarker for brain amyloid pathology as shown by:

‣ Positive plasma assay for Aβ(42)/ Aβ(40) ratio AND

⁃ Either postivie CSF assay for AD assessment or positive amyloid PET, per PI read.

• If receiving anti-dementia treatment (i.e. AChEI), be on stable treatment for at least 2 months (i.e., cholinesterase inhibitor and/or Memantine) before initial screening visit.

• Be stable on all other medications for at least 30 days prior to initial screening visit.

Locations
United States
Colorado
University of Colorado Anschutz Medical Campus
RECRUITING
Aurora
Contact Information
Primary
Neurology Research, CU Department of Neurology
NeuroResearch@cuanschutz.edu
303-724-4644
Time Frame
Start Date: 2022-06-01
Estimated Completion Date: 2027-10-31
Participants
Target number of participants: 42
Treatments
Experimental: Sargramostim
250 mcg/m2/day subcutaneously 5 days/week for 24 weeks
Placebo_comparator: Placebo Control - Saline
Placebo comparator (saline) subcutaneously 5days/week for 24 weeks
Related Therapeutic Areas
Sponsors
Collaborators: Alzheimer's Association, National Institute on Aging (NIA), Partner Therapeutics, Inc.
Leads: University of Colorado, Denver

This content was sourced from clinicaltrials.gov