Phase 2 Alzheimer's Disease Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged between 60 and 85 years old at the time of giving consent.
• People who have a dedicated partner or caregiver who spends at least 12 hours per week with them, can attend scheduled visits with them, and can give accurate reports about their behaviour, thinking, and daily functioning.
• People who are physically able to take part, with adequate vision and hearing.
• People who are willing and able to sign a consent or assent form.
• People who live close enough to the study site to attend regular visits, and who are also within reach of a local laboratory for blood draws.
• People who have been diagnosed with mild or moderate Alzheimer's disease (AD), or have a provisional research diagnosis consistent with mild or moderate AD, according to recognised research criteria — and who score between 4 and 24 on a standard memory and thinking test called the MoCA.
• People who have a positive blood test showing a specific protein ratio linked to Alzheimer's (Aβ42/Aβ40), AND either a positive spinal fluid (CSF) test or a positive brain scan (amyloid PET) confirming Alzheimer's-related brain changes.
• People who are already taking medication for dementia (such as a cholinesterase inhibitor or Memantine) and have been on a stable dose for at least 60 days before the first screening visit.
• People who have been on stable doses of all other medications for at least 30 days before the first screening visit.
• People who have had a dental check-up within 6 months of the screening date.

Who may not be able to join:

• People who have a parent, sibling, or child diagnosed with Alzheimer's disease before the age of 55.
• People with a Body Mass Index (BMI) of 35 or higher.
• People who are not able to read or write at a level needed to reliably complete thinking and memory assessments used in the trial.
• People who are currently imprisoned.
• People who have another neurological or psychiatric condition (other than Alzheimer's) that affects thinking or memory, or who have an unusual form of Alzheimer's or a related condition; or who have brain scan findings showing significant abnormalities unrelated to Alzheimer's (such as major stroke, brain infection, cancer, fluid on the brain, or multiple sclerosis); or whose spinal fluid results are not consistent with Alzheimer's.
• People who currently have a serious mood disorder, anxiety disorder, psychotic disorder, or substance-related disorder that — in the principal investigator's opinion — could affect thinking assessments, ability to complete the study, or interpretation of the study drug's effects; or people considered to be at risk of suicide or who show signs of suicidal thoughts.
• People with a history of blood clots in the legs (deep vein thrombosis), blood clots in the lungs (pulmonary embolism), or a family history of these conditions.
• People who have had an active cancer or tumour within the past 5 years, except for certain common non-spreading skin cancers; people with any history of leukaemia, regardless of whether it is in remission.
• People with a known allergy to latex or yeast.
• People with a known allergy or hypersensitivity to the study drug (sargramostim), yeast-derived products, any ingredient in the product, or benzyl alcohol (found in some injectable solutions).
• People who were born without a spleen, have a partially functioning spleen, or have had their spleen surgically removed.
• People with a history of, or who have received treatment for, an autoimmune disease (such as rheumatoid arthritis, multiple sclerosis, or myasthenia gravis).
• People with an untreated or unstable medical condition that could interfere with study assessments, or that may require immune-stimulating, immune-suppressing, or immune-modifying treatments during the trial.
• People with a history of seizures, except for febrile (fever-related) seizures in infancy.
• Women who are pregnant or breastfeeding, or women of childbearing potential who are not using a highly effective form of contraception and/or are unwilling to be tested for pregnancy; men whose partner could become pregnant and who are unwilling to use condoms.
• People whose MRI scan shows more than 4 small brain bleeds (micro-haemorrhages), or who may be more prone to a specific type of brain imaging abnormality associated with some Alzheimer's treatments.
• People whose laboratory test results indicate an untreated medical or blood-related condition that could increase risk or interfere with study assessments, in the investigator's judgement.
• People who have significant fluid retention in the body; breathing symptoms or moderate-to-severe lung disease (such as COPD); heart symptoms or heart disease findings on an ECG that require treatment (such as heart failure or uncontrolled irregular heartbeat); a resting heart rate below 50 beats per minute; a prolonged heart electrical interval on ECG (above 470ms for women or 450ms for men); or a blood pressure reading above 160 systolic and/or 95 diastolic at screening.
• People with known kidney problems, a creatinine level above 150 μmol/L, or a kidney filtration rate below 55 ml/min.
• People with known liver problems (except for a harmless condition called Gilbert's syndrome), or certain elevated liver enzyme levels on blood tests.
• People who test positive for hepatitis B, hepatitis C, HIV, or syphilis.
• People who cannot have an MRI or PET scan — for example, due to a pacemaker or certain metal implants in the body.
• People with a sensitivity to the radioactive substance used in PET scans (fluorodeoxyglucose F18).
• People whose past or planned exposure to radiation — combined with the radiation from PET scans used in this trial — would exceed recommended safety limits.
• People with poor vein access (making blood draws difficult).
• People with a history of chronic or repeated bacterial infections (confirm with trial site).
• People currently taking any medications or therapies prohibited by the trial.
• People who have taken part in another clinical trial involving an experimental drug within 60 days of screening, or within 5 times the time it takes that drug to leave the body — whichever is longer.
• People who have previously received an experimental treatment targeting amyloid or tau (proteins linked to Alzheimer's), or an Alzheimer's vaccine, unless it can be confirmed they received a placebo (inactive treatment) in that trial.
• People who have taken part in a clinical trial of the specific study drug (sargramostim) within 6 months of screening.
• People who, in the principal investigator's judgement, are likely to not follow the study plan — for example, due to plans to leave the area for extended periods or becoming separated from their designated caregiver during scheduled visits.
• People who are unable to cooperate due to a language barrier or a developmental disability.
• People who work on or oversee any part of this study, are employed by the sponsoring company or its affiliates, or are employees of the University of Colorado Alzheimer's and Cognition Center involved in conducting the study — or are a close family member of such a person.

Important: Always verify eligibility with the trial site directly before applying.