High dose treatments for alzheimer's disease
A reagent, a technology for use in the field of high-dose therapy for Alzheimer's disease
- Summary
- Abstract
- Description
- Claims
- Application Information
AI Technical Summary
Problems solved by technology
Method used
Image
Examples
Embodiment 1
[0458] Example 1 - A clinical study of the safety and tolerability of creizumab, a humanized anti-Aβ monoclonal antibody, administered to patients with mild to moderate Alzheimer's disease
[0459] A randomized, double-blind, phase I trial using placebo-controlled was conducted to evaluate the efficacy of the humanized monoclonal anti-amyloid beta ("Aβ") antibody creizumab in patients diagnosed with mild to moderate Alzheimer's disease. Safety, tolerability, and pharmacokinetics in patients with Merger's disease (AD). The study was designed to evaluate doses up to 8 times the dose administered to patients in a phase II clinical trial. Participants included in the study were between the ages of 50 and 90 at screening, had a Mini-Mental State Examination (MMSE) score of 18 to 28 points inclusive, and a Geriatric Depression Scale (GDS-15) score of less than 6 , a Clinical Dementia Rating-Global Score (CDR-GS) of 0.5 or 1.0, and a diagnosis of presumably mild to moderate Alzheime...
Embodiment 2
[0479] Example 2 - Clinical study of creizumab (a humanized anti-Aβ monoclonal antibody) in the treatment of prodromal to mild Alzheimer's disease
[0480] Research Design and Objectives
[0481] A multicenter, randomized, double-blind, placebo-controlled trial was conducted to confirm the role of the humanized monoclonal anti-amyloid beta ("Aβ") antibody creizumab in the diagnosis of prodromal to mild Alzheimer's disease Effects in amyloid-positive patients with Haimer's disease (AD). Participants in this study were aged between 50 and 85 at screening, had a weight between 40 kg and 120 kg (inclusive), had evidence of an AD pathological process, and were based on cerebrospinal fluid (CSF) amyloid β1- 42 levels of positive amyloid evaluation, as in Measured on the β-amyloid (1-42) test system or on the amyloid PET scan. Additional inclusion criteria were: (1) demonstrated abnormal memory function at screening with a Free and Cue Selective Recall Test-Recall Immediate (FCSR...
Embodiment 3
[0484] Example 3 - Exposure Response to Creizumab Supports 60 mg / kg Dose in Prodromal to Mild Alzheimer's Disease Treatment
[0485] method and objectives
[0486] For patients with milder forms of AD, the phase 2 study of creizumab demonstrated consistent therapeutic benefit at the 15 mg / kg intravenous dose, while the low 300 mg q2wk subcutaneous dose level lacked consistent therapeutic effect across endpoints, Suggesting that higher doses were associated with greater efficacy signals. In both phase 2 studies, creizumab was safe and well tolerated, supporting that the full therapeutic window has not yet been explored. A disease progression model of mild to moderate AD was established that simultaneously described longitudinal changes in the clinical endpoint ADAS-Cog and sum of CDR subitems (CDR-SB) in patients in the Phase 2 study. The model was extended to describe the effect of key demographic covariates on disease progression and the effect of creizumab on each endpoint...
PUM
Login to View More Abstract
Description
Claims
Application Information
Login to View More