Dementia Clinical Trial
Official title:
Investigating the Effect of Different Donanemab Dosing Regimens on ARIA-E and Amyloid Lowering in Adults With Early Symptomatic Alzheimer's Disease
This study will investigate different donanemab dosing regimens and their effect on the frequency and severity of ARIA-E in adults with early symptomatic Alzheimer's disease (AD) and explore participant characteristics that might predict risk of ARIA.
Status | Recruiting |
Enrollment | 800 |
Est. completion date | May 2025 |
Est. primary completion date | June 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 60 Years to 85 Years |
Eligibility | Inclusion Criteria: - Gradual and progressive change in memory function reported by the participant or informant for =6 months. - A mini mental state examination (MMSE) score of 20 to 28 (inclusive) at screening. - Have an amyloid PET scan result from central read, consistent with the presence of amyloid pathology. Exclusion Criteria: - Have significant neurological disease affecting the central nervous system other than AD, that may affect cognition or ability to complete the study, including but not limited to, other dementias, serious infection of the brain, Parkinson's disease, multiple concussions, or epilepsy or recurrent seizures, except febrile childhood seizures. - Has current serious or unstable illnesses including cardiovascular, hepatic, renal, gastroenterologic, respiratory, endocrinologic, neurologic (other than AD), psychiatric, immunologic, or hematologic disease and other conditions that, in the investigator's opinion, could interfere with the analyses in this study. - A life expectancy of <24 months - Have a presence or history of malignant neoplasms within the past 5 years prior to Visit 1. Exceptions: - non-metastatic basal- or squamous-cell skin cancer - Stage 0 non-invasive carcinoma of the cervix - Stage 0 non-invasive prostate cancer, or - other cancers with low risk of recurrence or spread - Contraindication to MRI or PET scans - Have had prior treatment with a passive anti-amyloid immunotherapy. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Re:Cognition Health - Birmingham | Birmingham | |
United Kingdom | Re:Cognition Health - Bristol | Bristol | Bristol, City Of |
United Kingdom | Re:Cognition Health Guildford | Guildford | Reading |
United Kingdom | Re:Cognition Health - London | London | London, City Of |
United Kingdom | Re:Cognition Health - Plymouth | Plymouth | |
United Kingdom | Re:Cognition Health - Winchester | Winchester | Hampshire |
United States | JEM Research Institute | Atlantis | Florida |
United States | VIN-Julie Schwartzbard | Aventura | Florida |
United States | Gadolin Research | Beaumont | Texas |
United States | Northwest Clinical Research Center | Bellevue | Washington |
United States | Excel Medical Clinical Trials | Boca Raton | Florida |
United States | MD First Research - Chandler | Chandler | Arizona |
United States | K2 Medical Research | Clermont | Florida |
United States | Columbus Memory Center, PC | Columbus | Georgia |
United States | Neurology Clinic, P.C. | Cordova | Tennessee |
United States | Kerwin Medical Center | Dallas | Texas |
United States | iResearch Atlanta | Decatur | Georgia |
United States | Brain Matters Research | Delray Beach | Florida |
United States | Re:Cognition Health | Fairfax | Virginia |
United States | QUEST Research Institute | Farmington Hills | Michigan |
United States | Neuropsychiatric Research Center of Southwest Florida | Fort Myers | Florida |
United States | Center for Advanced Research & Education | Gainesville | Georgia |
United States | Finlay Medical Research | Greenacres City | Florida |
United States | Infinity Clinical Research, LLC | Hollywood | Florida |
United States | The University of Texas Health Science Center at Houston | Houston | Texas |
United States | Irvine Clinical Research | Irvine | California |
United States | Encore Research Group- Jacksonville Center for Clinical Research | Jacksonville | Florida |
United States | Healthy Brain Clinic | Long Beach | California |
United States | ClinCloud - Maitland | Maitland | Florida |
United States | K2 Medical Research | Maitland | Florida |
United States | ClinCloud - Viera | Melbourne | Florida |
United States | Suncoast Clinical Research, Inc. | New Port Richey | Florida |
United States | Renstar Medical Research | Ocala | Florida |
United States | Charter Research - Winter Park | Orlando | Florida |
United States | Progressive Medical Research | Port Orange | Florida |
United States | Butler Hospital | Providence | Rhode Island |
United States | CenExel iResearch, LLC | Savannah | Georgia |
United States | California Neuroscience Research Medical Group, Inc. | Sherman Oaks | California |
United States | The Cognitive and Research Center of New Jersey | Springfield | New Jersey |
United States | Alzheimer's Research and Treatment Center | Stuart | Florida |
United States | Universal Research Group | Tacoma | Washington |
United States | K2 Medical Research - Tampa | Tampa | Florida |
United States | Charter Research - Lady Lake | The Villages | Florida |
United States | K2 Summit Research | The Villages | Florida |
United States | MedVadis Research Corporation | Waltham | Massachusetts |
United States | Adams Clinical | Watertown | Massachusetts |
United States | Alzheimer's Research and Treatment Center | Wellington | Florida |
United States | Palm Beach Neurology | West Palm Beach | Florida |
United States | Conquest Research | Winter Park | Florida |
Lead Sponsor | Collaborator |
---|---|
Eli Lilly and Company |
United States, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Participants with Any Occurence of Amyloid-Related Imaging Abnormality-Edema/Effusion (ARIA-E) | 24 Weeks | ||
Secondary | Percentage of Participants with Any Occurence of ARIA-E | 52 Weeks | ||
Secondary | Change from Baseline in Brain Amyloid Plaque Deposition As Measured By Amyloid Positron Emission Tomography (PET) Scan | Baseline, 76 Weeks | ||
Secondary | Percentage of Participants with Any Occurrence of Amyloid-Related Imaging Abnormality-Hemorrhage/Hemosiderin Deposits (ARIA-H) | 24 Weeks | ||
Secondary | Percentage of Participants with ARIA-H | 52 Weeks | ||
Secondary | Percentage of Participants with Maximum Severity of ARIA-E or ARIA-H | 52 Weeks | ||
Secondary | Pharmacokinetics (PK): Average Serum Concentration of Donanemab | Baseline to 52 Weeks | ||
Secondary | Number of Participants with Anti-Drug Antibodies (ADAs) Against Donanemab, including Treatment Emergent ADAs and Neutralizing Antibodies | Baseline to End of Follow-Up (91 Weeks) |
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