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.
Clinical Results
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
Referencia: http://www.nytimes.com/2015/03/21/business/alzheimers-drug-trial-shows-cognitive-decline-sharply-slowed.html?_r=1
Subida
por: Luis Mauricio Ortiz Gálvez.
