Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
NCT07923812, Recruiting, Fudan University
Trial 9
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study | ClinicalTrials.gov |
| NCT number | NCT07923812 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Enrollment | 3,000 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Fudan University | ClinicalTrials.gov |
| Conditions | Alzheimer's Disease (AD) | ClinicalTrials.gov |
| Interventions | Disease-Modifying Therapy | ClinicalTrials.gov |
| First posted | 2026-11-06 | ClinicalTrials.gov |
| Last updated | 2026-11-06 | ClinicalTrials.gov |
Registered outcomes 16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Safety of Disease-Modifying Therapy | From treatment initiation through up to 30 months of follow-up | To evaluate the safety of anti-amyloid disease-modifying therapies (DMTs; lecanemab or donanemab) in patients with Alzheimer's disease (AD)-related mild cognitive impairment (MCI) or AD dementia. Safety outcomes include the occurrence of amyloid-related imaging abnormalities (ARIA), and the number of patients experiencing, incidence proportion (%), and severity of treatment-related adverse events and infusion-related reactions (IRRs). | ClinicalTrials.gov |
| Primary | Clinical Effectiveness of Disease-Modifying Therapy | Baseline and follow-up assessments up to 30 months | To evaluate changes in Clinical Dementia Rating (CDR)-related measures in patients receiving anti-amyloid disease-modifying therapies (DMTs; lecanemab or donanemab) and those receiving usual care, and to compare these changes between the two groups. | ClinicalTrials.gov |
| Secondary | Change from baseline in Mini-Mental State Examination total score | Baseline and follow-up assessments up to 30 months | The Mini-Mental State Examination (MMSE) assesses global cognitive function. Total scores range from 0 to 30, with higher scores indicating better cognitive function. Change is calculated as the score at each available follow-up assessment minus the baseline score. Changes will be compared between the anti-amyloid treatment and usual-care cohorts. | ClinicalTrials.gov |
| Secondary | Change from baseline in Montreal Cognitive Assessment total score | Baseline and follow-up assessments up to 30 months | The Montreal Cognitive Assessment (MoCA) assesses global cognitive function. For the standard 30-point version, total scores range from 0 to 30, with higher scores indicating better cognitive function. Change is calculated as the score at each available follow-up assessment minus the baseline score. Changes will be compared between the anti-amyloid treatment and usual-care cohorts. The instrument version and education-adjustment rule will be recorded and applied consistently. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Amyloid Positron Emission Tomography (PET) Burden Measured in Centiloids | Baseline and follow-up assessments up to 30 months | Amyloid burden is quantified using Centiloid (CL) values. Higher values indicate greater amyloid burden. Change is calculated as the Centiloid value at each available follow-up examination minus the baseline value. Changes will be compared between the anti-amyloid treatment and usual-care cohorts. | ClinicalTrials.gov |
| Secondary | Duration of Disease-Modifying Therapy | From treatment initiation through up to 30 months of follow-up | Treatment duration will be calculated from the date of the first administration of lecanemab or donanemab to the date of the last administration within the observation period and expressed in months. | ClinicalTrials.gov |
| Secondary | Permanent Discontinuation of Disease-Modifying Therapy | From treatment initiation through up to 30 months of follow-up | The proportion of patients who permanently discontinue lecanemab or donanemab during follow-up will be assessed. Reasons for permanent treatment discontinuation will be recorded and summarized descriptively. | ClinicalTrials.gov |
| Secondary | Change from baseline in the 20-Item Activities of Daily Living Scale Score | Baseline and follow-up assessments up to 30 months | The 20-item Activities of Daily Living (ADL) Scale assesses functional independence in daily activities. Total scores range from 20 to 80, with higher scores indicating greater functional impairment. Change is calculated as the score at each available follow-up assessment minus the baseline score. Changes will be compared between the anti-amyloid treatment and usual-care cohorts. | ClinicalTrials.gov |
| Secondary | Change from baseline in Hamilton Anxiety Rating Scale total score | Baseline and follow-up assessments up to 30 months | The 14-item Hamilton Anxiety Rating Scale (HAMA) assesses anxiety symptom severity. Each item is scored from 0 to 4, yielding a total score from 0 to 56. Higher scores indicate more severe anxiety symptoms. Change is calculated as the score at each available follow-up assessment minus the baseline score. Changes will be compared between the anti-amyloid treatment and usual-care cohorts. | ClinicalTrials.gov |
| Secondary | Change from baseline in the 17-Item Hamilton Depression Rating ScaleTotal Score | Baseline and follow-up assessments up to 30 months | The 17-item Hamilton Depression Rating Scale (HAMD-17) assesses depressive symptom severity. Total scores range from 0 to 52, with higher scores indicating more severe depressive symptoms. Change is calculated as the score at each available follow-up assessment minus the baseline score. Changes will be compared between the anti-amyloid treatment and usual-care cohorts. | ClinicalTrials.gov |
| Secondary | Change from baseline in the 12-Item Neuropsychiatric Inventory Total Score | Baseline and follow-up assessments up to 30 months | The 12-item Neuropsychiatric Inventory (NPI-12) assesses neuropsychiatric symptom severity across 12 domains. Each domain score is calculated by multiplying symptom frequency (1-4) by severity (1-3), with a score of 0 assigned when symptoms are absent. The total score is the sum of the 12 domain scores and ranges from 0 to 144, with higher scores indicating greater neuropsychiatric symptom burden. Caregiver distress scores are not included in the total score. Change is calculated as the score at each available follow-up assessment minus the baseline score. Changes will be compared between the anti-amyloid treatment and usual-care cohorts. | ClinicalTrials.gov |
| Other | Change From Baseline in Plasma Phosphorylated Tau 217 Concentration | Baseline and follow-up assessments up to 30 months | Plasma phosphorylated tau 217 (p-tau217) concentration is measured to assess changes in Alzheimer's disease-related pathology. Change is calculated as the concentration at each available follow-up assessment minus the baseline concentration. Changes will be compared between the anti-amyloid treatment and usual-care cohorts. | ClinicalTrials.gov |
| Other | Change From Baseline in Plasma Glial Fibrillary Acidic Protein Concentration | Baseline and follow-up assessments up to 30 months | Plasma glial fibrillary acidic protein (GFAP) concentration is measured to assess changes in astrocytic activation. Change is calculated as the concentration at each available follow-up assessment minus the baseline concentration. Changes will be compared between the anti-amyloid treatment and usual-care cohorts. | ClinicalTrials.gov |
| Other | Change From Baseline in Plasma Neurofilament Light Chain Concentration | Baseline and follow-up assessments up to 30 months | Plasma neurofilament light chain (NfL) concentration is measured to assess changes in neuroaxonal injury. Change is calculated as the concentration at each available follow-up assessment minus the baseline concentration. Changes will be compared between the anti-amyloid treatment and usual-care cohorts. | ClinicalTrials.gov |
| Other | Change from baseline in tau positron emission tomography standardized uptake value ratio | Baseline and follow-up assessments up to 30 months | Tau burden is quantified using the standardized uptake value ratio (SUVR). Higher values indicate greater tau tracer uptake. Change is calculated as the SUVR at each available follow-up examination minus the baseline value. Changes will be evaluated in the anti-amyloid treatment cohort and compared with the usual-care cohort when sufficient paired data are available. | ClinicalTrials.gov |
| Other | Changes From Baseline in Magnetic Resonance Imaging (MRI) Findings | Baseline and follow-up assessments up to 30 months | Changes in brain structure will be assessed using quantitative magnetic resonance imaging (MRI) measures, including whole-brain volume, hippocampal volume, and other regional brain volumes. Change is calculated as the value at each available follow-up examination minus the baseline value. Changes will be compared between the anti-amyloid treatment and usual-care cohorts where data are available. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)