Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
Phase 2: testing Donanemab for Cognitive Dysfunction
The main purpose of this study is to evaluate whether treatment with donanemab slows the progression of cognitive (how we think, learn, remember, pay attention, and make decisions) and functional (how we are able to perform daily activities) decline. For each participant, the study will last one and a half years.
Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Donanemab, or Placebo. The registry lists allocation as randomized. The main purpose of this study is to evaluate whether treatment with donanemab slows the progression of cognitive (how we think, learn, remember, pay attention, and make decisions) and functional (how we are able to perform daily activities) decline.
They plan to enroll about 350 people at 72 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
A Phase 2 Randomized, Placebo-Controlled Clinical Trial to Assess the Safety and Efficacy of Donanemab in Participants With Early Cognitive Decline, at Least One Core Clinical Feature of Dementia With Lewy Bodies, and Confirmation of Alpha-Synuclein and Amyloid Co-pathology
Primary outcome (registry wording): Change from Baseline on Clinical Dementia Rating - Sum of Boxes (CDR-SB)
Who it is for (from inclusion criteria)
Ages 55 Years to 85 Years
Have gradual and progressive cognitive decline for greater than or equal to ( ≥) 6 months
Have least 1 core clinical feature of dementia with Lewy bodies (DLB)
Have a score ≥20 on Montreal Cognitive Assessment (MoCA)
Meet plasma P-tau217 criteria
Have a cerebrospinal fluid (CSF) result consistent with the presence of brain amyloid pathology
Have a CSF result consistent with the presence of alpha-synuclein pathology
Who the registry excludes
Have a disease or condition that could interfere with this study or is a current serious or unstable illness
Have, or is suspected to have, a significant neurological disease (other than the studied condition) that affects the central nervous system and may affect the individual's cognition or ability to complete the study
Have a history of cancer that, in the investigator's opinion, has a high risk of recurrence and preventing the completion of the study
Have clinically significant multiple or severe drug allergies, significant atopy, or severe posttreatment hypersensitivity reactions
Have previously received amyloid-targeting therapy
Active immunization against amyloid-beta
Have a centrally read MRI that does not meet study entry criteria
Public study contact (from the registry)
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
The specific aims of the study are: Primary: To determine the presence and regional distribution of microglial activation, as assessed by Fluorine-18 (18F) labeled "Peripheral Benzodiazepine Receptor 06" (PBR06) -PET, in subjects with active Relapsing Remitting Multiple Sclerosis (RRMS), Secondary Progressive Multiple Sclerosis (SPMS), and Alzheimer's Disease (AD) as compared to healthy controls Secondary: 1. To assess the relationship between microglial activation and clinical variables including disease severity and comorbidities (such as pain, fatigue and/or depression), as well as clinical MRI findings (such as lesions and atrophy) 2.
This study will look at whether nabilone is an effective treatment for agitation in Alzheimer's disease (AD) patients. Agitation is highly prevalent in patients with AD and is one of the most distressing and challenging-to-treat symptoms.
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07589595?
Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07589595?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.