A Study to Evaluate Efficacy and Safety of Intravenous Sabirnetug in Participants With Early Alzheimer's Disease (ALTITUDE-AD)
Condition(s) studied
Investigational drug(s) / intervention(s)
sabirnetug: Intravenous sabirnetug
Placebo: Intravenous Placebo
Study summary
The primary purpose of this study is to evaluate the efficacy of sabirnetug infusions administered once every four weeks (Q4W) in slowing cognitive and functional decline as compared to placebo in participants with early Alzheimer's disease.
Eligibility
Primary outcome measure(s)
- Change from Baseline in Integrated Alzheimer's Disease Rating Scale (iADRS) Score — Baseline up to Week 80
iADRS is a validated composite of cognition and function made up of Alzheimer's Disease Assessment Scale - Cognitive Subscale 13-item (ADAS-Cog13) and the Alzheimer's Disease Cooperative Study - instrumental Activities of Daily Living scale (ADCS-iADL). ADAS-Cog13 is a rater-administered instrument consisting of 13 items assessing cognitive function areas most typically impaired in AD. ADAS-Cog13 scores range from 0 to 85, with higher scores indicating a greater deficit of global cognition. The ADCS-iADL is a subset of the 23-item ADCS-ADL (items 6a and 7 to 23). The iADLs are more complex skills required to successfully live independently. iADL-items score ranges from 0 to 59 (lower scores indicating greater impairment). The iADRS is calculated as a linear combination of total scores from the ADAS-Cog13 and ADCS-iADL. The iADRS score ranges from 0 to 144 with lower scores indicating worse performance.
Trial sites (68)
| Facility | City | Region | Status |
|---|---|---|---|
| The Neurology Center of Southern California - Carlsbad | Carlsbad | California | |
| Neurology Center of North Orange County | Fullerton | California | |
| Irvine Medical Research | Irvine | California | |
| Healthy Brain Research | Long Beach | California | |
| Syrentis Clinical Research | Santa Ana | California | |
| CenExel - California Neuroscience Research Medical Group, Inc (CNR) | Sherman Oaks | California | |
| Research Center for Clinical Studies, LLC | Norwalk | Connecticut | |
| Re:Cognition Health - Fairfax | Washington D.C. | District of Columbia | |
| JEM Research Institute | Atlantis | Florida | |
| Bradenton Research Center | Bradenton | Florida | |
| Gil Fernandez-Yera, MD, PA | Coral Gables | Florida | |
| Brain Matters Research | Delray Beach | Florida | |
| Coral Clinical Research | Homestead | Florida | |
| K2 Medical Research - Villages | Lady Lake | Florida | |
| Finlay Medical Research | Miami | Florida | |
| Aqualane Clinical Research | Naples | Florida | |
| Ocala Health - Family Care Specialists - Ocala I | Ocala | Florida | |
| Progressive Medical Research | Port Orange | Florida | |
| Alzheimer's Research and Treatment Center - Stuart | Stuart | Florida | |
| K2 Medical Research - Tampa | Tampa | Florida | |
| Charter Research - Lady Lake | The Villages | Florida | |
| Alzheimers Research and Treatment Center - Wellington | Wellington | Florida | |
| Conquest Research | Winter Park | Florida | |
| Charter Research - Winter Park | Winter Park | Florida | |
| Columbus Memory Center | Columbus | Georgia | |
| CenExel - iResearch Atlanta | Decatur | Georgia | |
| Office of Jeffrey S. Ross, MD | Northbrook | Illinois | |
| Boston Center for Memory | Newton | Massachusetts | |
| Hattiesburg Clinic - Memory Center | Hattiesburg | Mississippi | |
| ActivMed Practices and Research | Portsmouth | New Hampshire | |
| The Cognitive and Research Center of New Jersey | Springfield | New Jersey | |
| CenExel - Advanced Memory Research Institute of NJ | Toms River | New Jersey | |
| Neurological Associates of Albany | Albany | New York | |
| AMC Research | Matthews | North Carolina | |
| Cleveland Clinic | Cleveland | Ohio | |
| Summit Research Network | Portland | Oregon | |
| Abington Neurological Associates | Abington | Pennsylvania | |
| Keystone Clinical Research | Norristown | Pennsylvania | |
| Rhode Island Mood and Memory | East Providence | Rhode Island | |
| Neurology Clinic. P.C | Cordova | Tennessee |
+ 28 more sites — see the full list on the official registry below.
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06335173 on ClinicalTrials.gov ↗ ← All trials in Spain