La compañía Biogen Idec ha mostrado un avance de sus análisis de su investigación sobre el tratamiento del Alzheimer, y el fármaco llamado "aducanumab"; todo lo anterior, fue presentado en “12th International Conference on Alzheimer's and Parkinson's Diseases and Related Neurological Disorders”, en Francia.
Presentaré lo que dicen en su página web:
Radiologic Results for Amyloid Plaque
In patients receiving aducanumab, a dose- and time-dependent reduction of amyloid plaque was observed over 54 weeks of treatment.
PET imaging using the radiotracer florbetapir1, which binds to amyloid plaque, was used to measure plaque levels in the brain. A composite standardized uptake value ratio (SUVR) of six regions of the brain –frontal, parietal, lateral temporal, sensorimotor, anterior and posterior cingulate – was calculated at baseline, at 26 weeks and at 54 weeks using whole cerebellum as a reference.
In the placebo arm, the SUVR was virtually unchanged at 26 and 54 weeks. Aducanumab treatment resulted in a statistically significant reduction of amyloid plaque in the 3 mg/kg [average change of -0.087, p<0.01)], 6 mg/kg [-0.143 (p<0.001)] and 10 mg/kg [-0.205 (p<0.001)] dose arms compared to placebo at 26 weeks. Amyloid plaque levels were reduced by -0.030 in the 1 mg/kg arm, which was not significant.
At week 54, a statistically significant reduction of amyloid plaque was observed in the 3 mg/kg [-0.139 (p<0.001)] and 10 mg/kg [-0.266 (p<0.001)] dose arms. The reduction of amyloid plaque in the 1 mg/kg (-0.056) arm was not significant. The 6 mg/kg arm is ongoing and the week 54 data will become available at a later date.
The effect of aducanumab on AD-related impairment was measured using the MMSE and Clinical Dementia Rating sum of boxes (CDR-SB). The MMSE is used to assess a patient’s cognitive status and the CDR-SB characterizes a patient’s cognitive and functional performance.
On the MMSE, patients in the placebo group worsened by an average of 3.14 at one year, whereas the decline was 2.21 in the 1 mg/kg arm, 0.75 in the 3 mg/kg arm and 0.58 in the 10 mg/kg arm. Relative to placebo, the 3 mg/kg and 10 mg/kg doses demonstrated a statistically significant slowing of cognitive decline on the MMSE, both with p-values <0.05.
On the CDR-SB, patients in the placebo group worsened by an average of 2.04 at one year. In comparison, the worsening was 1.70 in the 1 mg/kg arm, 1.33 in the 3 mg/kg arm and 0.59 in the 10 mg/kg arm. Relative to placebo, the 10 mg/kg showed a statistically significant slowing of clinical decline on the CDR-SB with p-value <0.05.
Pharmacokinetic activity and exposure were linear with dose. Treatment-emergent immunogenicity, which occurred in approximately 3 percent of patients, was transient and without apparent effect on aducanumab PK.
Lean más de sus resultados, en: http://www.biogenidec.com/press_release_details.aspx?ID=14712&Action=1&NewsId=2486&M=NewsV2&PID=61997
Subida por: Luis Mauricio Ortiz Gálvez.