nctId: NCT06335173 id: ACU193-201 id: 2023-509807-34-00 type: REGISTRY domain: EU CT Number briefTitle: A Study to Evaluate Efficacy and Safety of Intravenous ACU193 in Participants With Early Alzheimer's Disease (ALTITUDE-AD) acronym: ALTITUDE-AD overallStatus: RECRUITING date: 2024-02-29 date: 2031-01 date: 2031-01 date: 2024-03-28 date: 2024-03-29 name: Acumen Pharmaceuticals class: INDUSTRY briefSummary: The primary purpose of this study is to evaluate the efficacy of ACU193 infusions administered once every four weeks (Q4W) in slowing cognitive and functional decline as compared to placebo in participants with early Alzheimer's disease. conditions: Alzheimer Disease studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 2040 type: ESTIMATED name: ACU193 name: Placebo measure: Change from Baseline in Integrated Alzheimer's Disease Rating Scale (iADRS) Score measure: Change from Baseline in ADCS-iADL Score measure: Change from Baseline in ADAS-Cog13 Score measure: Change from Baseline in Clinical Dementia Rating - Sum of Boxes (CDR-SB) measure: Change from Baseline in Mini-Mental State Examination (MMSE) measure: Change from Baseline in Quality of Life in Alzheimer's Disease (QoL-AD) measure: Change from Baseline in Neuropsychiatric Inventory Questionnaire (NPI-Q) Score measure: Change from Baseline in EuroQoL 5-Dimension 5-Level (EQ-5D-5L) measure: Change from Baseline in Resource Utilization in Dementia (RUD) measure: Change from Baseline in Zarit Burden Interview (ZBI) measure: Effect of ACU193 on Clinical Progression as Compared to Placebo Assessed Using Time Saved Analysis as Measured by iADRS measure: Effect of ACU193 on Clinical Progression as Compared to Placebo Assessed Using Time Saved Analysis as Measured by ADCS-iADL measure: Effect of ACU193 on Clinical Progression as Compared to Placebo Assessed Using Time Saved Analysis as Measured by ADAS-Cog13 measure: Effect of ACU193 on Clinical Progression as Compared to Placebo Assessed Using Time Saved Analysis as Measured by CDR-SB measure: Effect of ACU193 on Clinical Progression as Compared to Placebo Assessed Using Time Saved Analysis as Measured by MMSE measure: Percentage of Participants with No Clinical Progression at One Year measure: Number of Participants with Treatment-Related Adverse Events (TEAEs) measure: Number of Participants with Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI) measure: Number of Participants who Discontinue or Withdraw due to TEAE measure: Number of Participants with Anti-Drug Antibodies (ADA) and Neutralizing Antibodies measure: Number of Participants with Amyloid-Related Imaging Abnormality with Edema/Effusions (ARIA-E) and ARIA with Hemorrhage/Hemosiderin Deposition (ARIA-H) as Measured by Magnetic Resonance Imaging (MRI) measure: Number of Participants with Suicidal Ideation and Behavior as Measured by Columbia-Suicide Severity Rating Scale (C-SSRS) measure: Serum Concentration of ACU193 measure: Concentration of ACU193 in Cerebrospinal Fluid (CSF) measure: CSF Concentrations of ACU193 in a Subset of Participants measure: Correlation Between ACU193 Exposure with Clinical Efficacy Measures measure: Change From Baseline in Amyloid Plaque Load or Deposition Measured by Positron Emission Tomography (PET) in Centiloids measure: Change from Baseline in Volumetric Magnetic Resonance Imaging (vMRI) of Whole Brain Volume, Ventricular Volume, and Volume of Selected Regions of Interest measure: Target Engagement Assessed by Measurement of ACU193- Amyloid-β oligomer (AβO) Complex in CSF measure: Change from Baseline in CSF Concentrations of Amyloid, Tau and Other Neurodegenerative Biomarkers measure: Change from Baseline in CSF Concentrations of Amyloid, Tau, and Other Neurodegenerative Biomarkers in a Subset of Participants measure: Change from Baseline in Blood Concentrations of Amyloid, Tau, and Other Neurodegenerative Biomarkers measure: Correlation Between Change in Biomarker that Reflect Disease Progression and Clinical Changes sex: ALL minimumAge: 50 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Banner Alzheimer's Institute- Clinical Trials Department status: NOT_YET_RECRUITING city: Phoenix state: Arizona zip: 85006 country: United States lat: 33.44838 lon: -112.07404 facility: IMA Clinical Research - 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California Neuroscience Research Medical Group, Inc (CNR) status: NOT_YET_RECRUITING city: Sherman Oaks state: California zip: 91403-2131 country: United States lat: 34.15112 lon: -118.44925 facility: Alpine Clinical Research Center status: NOT_YET_RECRUITING city: Boulder state: Colorado zip: 80301-1880 country: United States lat: 40.01499 lon: -105.27055 facility: The Mile High Research Center status: NOT_YET_RECRUITING city: Denver state: Colorado zip: 80218 country: United States lat: 39.73915 lon: -104.9847 facility: Yale School of Medicine - Alzheimer's Disease Research Unit (ADRU) status: NOT_YET_RECRUITING city: New Haven state: Connecticut zip: 06510-3330 country: United States lat: 41.30815 lon: -72.92816 facility: Research Center for Clinical Studies, LLC status: NOT_YET_RECRUITING city: Norwalk state: Connecticut zip: 06851-4903 country: United States lat: 41.1176 lon: -73.4079 facility: Re:Cognition Health - Fairfax status: NOT_YET_RECRUITING city: Washington state: District of Columbia zip: 22031 country: United States lat: 38.89511 lon: -77.03637 facility: JEM Research Institute status: RECRUITING city: Atlantis state: Florida zip: 33462 country: United States name: Clinical Research Coordinator role: CONTACT phone: 561-968-2933 email: research@jemri.net lat: 26.5909 lon: -80.10088 facility: Bradenton Research Center status: NOT_YET_RECRUITING city: Bradenton state: Florida zip: 34205 country: United States lat: 27.49893 lon: -82.57482 facility: Gil Fernandez-Yera, MD, PA status: NOT_YET_RECRUITING city: Coral Gables state: Florida zip: 33135 country: United States lat: 25.72149 lon: -80.26838 facility: Brain Matters Research status: NOT_YET_RECRUITING city: Delray Beach state: Florida zip: 33445 country: United States lat: 26.46146 lon: -80.07282 facility: Coral Clinical Research status: NOT_YET_RECRUITING city: Homestead state: Florida zip: 33032 country: United States lat: 25.46872 lon: -80.47756 facility: K2 Medical Research - Villages status: RECRUITING city: Lady Lake state: Florida zip: 32159 country: United States name: Kylie Webster role: CONTACT phone: 352-565-7524 email: kylie.webster@k2med.com lat: 28.91749 lon: -81.92286 facility: Verus Clinical Research status: NOT_YET_RECRUITING city: Miami state: Florida zip: 33125 country: United States lat: 25.77427 lon: -80.19366 facility: Finlay Medical Research status: NOT_YET_RECRUITING city: Miami state: Florida zip: 33126 country: United States lat: 25.77427 lon: -80.19366 facility: Collier Neurologic Specialists (CNS), L.L.C. status: NOT_YET_RECRUITING city: Naples state: Florida zip: 34105-8522 country: United States lat: 26.14234 lon: -81.79596 facility: Ocala Health - Family Care Specialists - Ocala I status: NOT_YET_RECRUITING city: Ocala state: Florida zip: 34470 country: United States lat: 29.1872 lon: -82.14009 facility: Progressive Medical Research status: NOT_YET_RECRUITING city: Port Orange state: Florida zip: 32127 country: United States lat: 29.13832 lon: -80.99561 facility: Alzheimer's Research and Treatment Center - 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