Eligibility Criteria for SESAD Research Study

Inclusion Criteria

 You may be eligible for this research study if you:

• Are between the ages of 60-85
• Have a study partner with whom you at least 12 hours of contact a week, is willing to attend scheduled visits, can report changes in your thinking and memory, and is willing to be trained to give daily injections of study drug
• Don’t have any physical, visual or auditory impairments that would limit participation in study procedures (e.g, tests of your memory and thinking abilities, laying flat for imaging and heart tests, etc.)
• Have a legally authorized representative or designated medical proxy who can provide consent on your behalf if you are unable to provide consent for yourself
• Live reasonably close to the University of Colorado Anschutz Medical Campus and a local LabCorp, to complete study visits during the treatment period (2-3 time per week between the two locations).
• Have a diagnosis of mild-moderate Alzheimer’s disease
• Are within range on cognitive screening exam
• Are willing to have testing of sample collected from a lumbar puncture/spinal tap or an amyloid PET scan to confirm diagnosis of Alzheimer’s disease
• Are stable on Alzheimer’s disease medication for at least 60 days before screening visit, and stable on all other medications for at least 30 days before screening visit. 

Exclusion Criteria

You may not be eligible for this research study if you:

• Have a first degree relative diagnosed with AD before 55 years of age
• Have an atypical form of dementia (e.g., Posterior Cortical Atrophy, logopenic primary progressive aphasia, frontotemporal dementia)
• Have other neurological conditions that may affect your memory or thinking (e.g., major stroke, brain infection, brain cancer, multiple sclerosis)
• Have current serious mood, anxiety, or other related psychological disorders according to the DSM-V that the research investigator feels could impact research study participation
• Have had alcohol or substance abuse or dependence in the last 2 years
• Have a Body Mass Index (BMI) greater than or equal to 35 (calculate BMI here)
• Have a history of deep vein thrombosis, pulmonary embolism, or a family history that increases your risk for deep vein thrombosis or pulmonary embolism
• Have active cancer other than non-melanoma skin cancer
• Have a prior diagnosis of leukemia or have been diagnosed with hyperleukocytic syndrome (including, but not restricted to, chronic myelogenous leukemia, Hodgkin and non-Hodgkin lymphoma), monoclonal gammopathy, or thrombocythemia
• Have current or past allergies or hypersensitivity to any of the following substances:

• Latex
• Yeast or yeast derived-products
• Benzyl alcohol
• Bacteriostatic water
• Saline
• Sargramostim or any ingredients in Sargramostim

• Have ever had any issues related to your spleen, including asplenia, hyposplenia, or a splenectomy
• Have a history of or treatment for any autoimmune conditions (e.g., multiple sclerosis, rheumatoid arthritis, myasthenia gravis, etc.
• Have a history of seizures, other than infant febrile seizures
• Have untreated or poorly controlled conditions such as hyperthyroidism, hypothyroidism, or vitamin B-12 deficiency
• Have MRI evidence of 4 or more micro-hemorrhages
• Have the following lung or heart conditions

• Problems with fluid retention that make it hard to do normal daily activities
• Problems with difficulty breathing, to a point that it is hard to do your normal activities (e.g., dyspnea)
• Moderate lung disease (e.g., chronic obstructive pulmonary disease – COPD)
• Heart conditions or evidence of heart conditions from a heart tracing (electrocardiogram; ECG) that require treatment (e.g., congestive heart failure, supraventricular arrhythmia, heart block, or uncontrolled atrial fibrillation)
• Low heartrate that is usually under 50 beats per minute
• Extremely high blood pressure, which we usually think about as being greater than 160 systolic (top number) or 95 diastolic (bottom number)               

• Have any conditions that cause kidney or liver dysfunction, other than Gilbert’s syndrome
• Currently have, or have a history of, HIV, hepatitis-B, hepatitis-C, or syphilis infections
• Have a sensitivity to fluorodeoxyglucose F18, which is used for the FDG PET scan
• Have lifetime or current radiation exposures that would prohibit study PET scans
• Are unwilling or unable to have an MRI  or PET scan(e.g., pacemaker or metal implants that are not MRI safe)
• Are unwilling or unable to have a lumbar puncture/spinal tap (e.g., history of spinal surgery or significant deformity to the lumbar or sacral (lower) area of your spine, take anticoagulant medications (blood thinners) other than daily aspirin)
• Have chronic use of non-steroid anti-inflammatory drugs (NSAIDS), except for daily 81 mg aspirin – chronic use for this research study is defined as 3 or more times a week for more than 2 weeks in a month (e.g., ibuprofen/Advil, Aleve, Naproxen)
• Have chronic use of anti-cholinergic drugs (e.g., atropine, etc.)
• Have chronic use of corticosteroids or have taken them in the last 4 weeks prior to screening
• Take the medication lithium (also called Eskalith or Lithobid)
• Have started or stopped taking diuretics in the last 4 weeks
• Have taken the following medications during the 4 weeks:

• Neuroleptics (e.g., chlorpromazine/Thorazine, fluphenazine/Prolixin, loxapine/Loxitane, perphenazine/Etrafon/Trilafon, thioridazine/Mellaril, thiothixene/Navane, trifluoperazine/Stelazine, clozapine/Clozaril, haloperidol/Haldol, olanzapine/Zyprexa, quetiapine/Seroquel, etc. There are some neuroleptics that are permitted, these include aripiprazole/Abilify, risperidone/Risperdal (up to 2mg/day), and ziprasidone/Geodon)
• Anti-parkinsonian medications (e.g., amantadine/Symmetrel, bromocriptine/Parlodel, deprenyl/selegilene/Eldepry, levodopa/Sinement, pergolide/Permax, pramipexole/Mirapex)
• Sedative or benzodiazepine medications (e.g., chlordiazepoxide/Librium, clonazepam/Klonopin, diazepam/Valium, flurazepam/Dalmane, meprobamate/Miltown, triazolam/Halcion.  There are some benzodiazepine medications allowed if doses have been stable for 4 weeks prior to the first screening appointment, these include alprazolam/Xanax, buspirone/Buspar, chloral hydrate/Noctec, lorazepam/Ativan, oxazepam/Serax, temazepam/Restoril, trazodone/Desyrel, zalelon/Sonata, zolpidem/Ambien)
• Rheumatoid Arthritis medications (e.g., abatacept/Orencia, adalimumab/Humira, anakirna/Kinert, barictinib/Olumiant, betamethasone/Celestone, certolizmab/Cimzia, etanercept/Enbrel, golimumab/Simponi, hydroxichloroquine sulfate/Plaquenil, infliximab-dyb/Inflecra/Remicade, leflunomide/Arava, methotrexate/Rheumatrex/Trexall, prednisone, rituximab/Rituxan, sarilumab/Kevzara, Tocilizumab/Actemra, tofacitinib/Xeljanz)

• Have taken the following medications in the last 60 days

• Immune modulatory or immune suppressant medications (e.g., cyclosporine/Neoral/Sandimmune/SangCya, tacrolimus/Astagraf XL/ Envarsus XR/Prograf, sirolimus/Rapamune, everolimus/Afinitor/Zortress, azathioprine/Azasan/Imuran, lefunomide/Avara, mycophenolate/CellCept/Myfortic, ixekizumab/Taltz, natalizumab/Tysabi, secukinumab/Consentyx, ustekinumab/Stelara, vedolizumab/Entyvio, basiliximab/Simulect, daclizumab/Zinbryta)

• Take the anti-hypertension medication clonidine/Catapres
• Take leukotriene inhibitors, such as montelukast for an off label reason
• Have received an investigational drug within 60 days of screening or within 5 times the elimination half-life of that drug, whichever is longest
• Have prior treatment with an investigational anti-amyloid or anti-tau therapy or Alzheimer’s Disease vaccine, unless you can provide documentation that you were on placebo
• Have participated in the treatment phase of an investigational Sargramostim clinical trial within 6 months of screening
• Are a child-bearing female, or male with a female partner who could become pregnant, and refuse to use a highly effective form of birth control or condoms throughout the study period.
• Oversee any aspect of this study, are an employee of Partner Therapeutics and its affiliates/subsidiaries, are an employee of the CU Alzheimer’s and Cognition Center and are engaged in the conduct of this study, or are a first degree relative of such
• Have difficulties reading or writing to a level where you cannot participate in cognitive testing and health questionnaires provided in English
• Are a prisoner