Trial · NCT04902703
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety as measured by number of Adverse Events (AEs) by body system | Informed consent to Follow-up Visit (38 weeks) | The safety of sargramostim will be assessed through number of adverse events (AEs) by body system from consent to follow-up within a safety analysis set consisting of all individuals who were enrolled and and randomized and who received at least one injection of sargramostim or placebo. |
| Secondary | Mini-Mental State Examination | Baseline to End of Treatment, Follow-up (30 weeks) | Mini-Mental State Examination (MMSE) is a brief psychometric instrument developed to assess cognitive function in elderly populations. It is a standard assessment used by all NIH Alzheimer's Disease Centers (ADCCs and ADRCs) to identify and monitor individuals with AD. The range for scores in the MMSE is from 0 to 30, with lower scores indicating greater impairment. |
| Other | Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-Cog13) | Baseline to End of Treatment, Follow-up (30 weeks) | The ADAS-Cog13 measures the severity of the most important symptoms of AD. and consists of 13 tasks measuring the disturbances of memory, language, praxis, attention and other cognitive abilities. , which are often referred to as the core symptoms of AD. The score ranges form 0-85, with higher score denoting worse performance |
| Other | Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) | Baseline to End of Treatment, Follow-up (30 weeks) | The CDR is a study partner/caregiver and participant based interview to assess changes in domains such as memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. Each domain is rated as 0 (no dementia), 0.5 (uncertain dementia), 1 (mild dementia), 2 (moderate dementia), or 3 (severe dementia). Range is 0-18. Higher scores denote worse functioning |
| Other | Trail Making Test - Part A (TMT-A) | Baseline to End of Treatment, Follow-up (30 weeks) | Psychomotor speed will be assessed by the Trail Making Test-A, a timed test in which participants must connect a series of numbers randomly placed on a page. Time range is 0-150 seconds, with a higher time denoting worse performance |
| Other | Alzheimer's Disease Cooperative Study -Activities of Daily Living Inventory (ADCS-ADL) | Baseline to End of Treatment, Follow-up (30 weeks) | The ADCS-ADL is a caregiver/study partner rated questionnaire of 23 items, with possible scores over a range of 0-78, where 78 implies full functioning with no impairment. |
| Other | Montreal Cognitive Assessment (MoCA) | Baseline to End of Treatment, Follow-up (30 weeks) | The Montreal Cognitive Assessment (MoCA) is a brief, assessment developed for detection and tracking of cognitive impairment and is sensitive for detecting Alzheimer's disease. Measuring multiple domains, it is commonly used in both clinical and research settings, and is well validated, with a range of scores from 0-30. |
| Other | Neuropsychiatric Inventory (NPI) | Baseline to End of Treatment, Follow-up (30 weeks) | Neuropsychiatric Inventory (NPI) is a study partner/caregiver interview to assess any changes in neuropsychiatric status in such domains as hallucinations, delusions, agitation, depression, anxiety, disinhibition, apathy and aberrant motor behaviors. It assesses presence of symptoms, and scores by severity X frequency (Range 0-12 in each symptom category), and caregiver distress (Range 0-5). The higher the scores, the the greater the presence of the impact of the symptom. |
| Other | Verbal Fluency | Baseline to End of Treatment, Follow-up (30 weeks) | Verbal fluency (producing words that start with a specific letter of the alphabet, also known as letter fluency) is a timed test where a participant produces as many works as they can in 60 seconds. The more correct words that a participant produces, the higher the score. |
| Other | Semantic Fluency | Baseline to End of Treatment, Follow-up (30 weeks) | Semantic fluency (producing words that belong in a category, such as animals, also known as category fluency) is a timed test where a participant produces as many works as they can in 60 seconds within a category. The more correct words that a participant produces, the higher the score. |
| Other | Exploratory: Fluorodeoxyglucose Positron Emission Tomography (FDG PET) assessment of brain metabolism | Baseline to End of Treatment (24 weeks) | FDG-PET assessment of metabolic activity, overall, as well in different brain regions, particularly in the medial temporal lobe in potential correlation with changes in MTA |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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