[ExI] Alzheimer's vaccine trial a success

James Clement clementlawyer at gmail.com
Thu Jul 12 05:24:36 UTC 2012

\On Fri, Jun 8, 2012 at 2:16 AM, BillK <pharos at gmail.com> wrote:

> [NEWS 6 June] A study led by Karolinska Institutet reports for the
> first time the positive effects of an active vaccine against
> Alzheimer's disease. The new vaccine, CAD106, can prove a breakthrough
> in the search for a cure for this seriously debilitating dementia
> disease. The study is published in the distinguished scientific
> journal Lancet Neurology.
> <http://ki.se/ki/jsp/polopoly.jsp?l=en&d=130&a=145109&newsdep=130>

This was just a phase-one clinical study, meaning their objective was to
determine whether anyone would die or get a terrible side effect from the
treatment.  Here's the summary from the Lancet Neurology:

The Lancet Neurology, Volume 11, Issue
Pages 597 - 604, July 2012
<Previous Article<http://www.thelancet.com/journals/laneur/article/PIIS1474-4422(12)70106-0/fulltext>
|Next Article<http://www.thelancet.com/journals/laneur/article/PIIS1474-4422(12)70098-4/fulltext>
or Link Using DOI <http://www.thelancet.com/popup?fileName=cite-using-doi>
This article can be found in the following collections:
Published Online: 06 June 2012
Safety, tolerability, and antibody response of active Aβ immunotherapy with
CAD106 in patients with Alzheimer's disease: randomised, double-blind,
placebo-controlled, first-in-human study
Prof Bengt Winblad<http://www.thelancet.com/search/results?fieldName=Authors&searchTerm=Bengt+Winblad>
 MD a<http://www.thelancet.com/journals/laneur/article/PIIS1474-4422(12)70140-0/fulltext#aff1>
 [image: Corresponding
Email Address] <bengt.winblad at ki.se>, Niels
 MD a<http://www.thelancet.com/journals/laneur/article/PIIS1474-4422(12)70140-0/fulltext#aff1>
, Prof Lennart Minthon<http://www.thelancet.com/search/results?fieldName=Authors&searchTerm=Lennart+Minthon>
 MD b<http://www.thelancet.com/journals/laneur/article/PIIS1474-4422(12)70140-0/fulltext#aff2>
, Annette Floesser<http://www.thelancet.com/search/results?fieldName=Authors&searchTerm=Annette+Floesser>
 MSc c<http://www.thelancet.com/journals/laneur/article/PIIS1474-4422(12)70140-0/fulltext#aff3>
, Georges Imbert<http://www.thelancet.com/search/results?fieldName=Authors&searchTerm=Georges+Imbert>
 PhD c<http://www.thelancet.com/journals/laneur/article/PIIS1474-4422(12)70140-0/fulltext#aff3>
,Thomas Dumortier<http://www.thelancet.com/search/results?fieldName=Authors&searchTerm=Thomas+Dumortier>
 MSc d<http://www.thelancet.com/journals/laneur/article/PIIS1474-4422(12)70140-0/fulltext#aff4>
, R Paul Maguire<http://www.thelancet.com/search/results?fieldName=Authors&searchTerm=R%20Paul+Maguire>
 PhD c<http://www.thelancet.com/journals/laneur/article/PIIS1474-4422(12)70140-0/fulltext#aff3>
, Kaj Blennow<http://www.thelancet.com/search/results?fieldName=Authors&searchTerm=Kaj+Blennow>
 MD e<http://www.thelancet.com/journals/laneur/article/PIIS1474-4422(12)70140-0/fulltext#aff5>
, Joens Lundmark<http://www.thelancet.com/search/results?fieldName=Authors&searchTerm=Joens+Lundmark>
 MD f<http://www.thelancet.com/journals/laneur/article/PIIS1474-4422(12)70140-0/fulltext#aff6>
, Matthias Staufenbiel<http://www.thelancet.com/search/results?fieldName=Authors&searchTerm=Matthias+Staufenbiel>
 PhD c<http://www.thelancet.com/journals/laneur/article/PIIS1474-4422(12)70140-0/fulltext#aff3>
, Prof Jean-Marc
 MD g<http://www.thelancet.com/journals/laneur/article/PIIS1474-4422(12)70140-0/fulltext#aff7>
, Ana Graf<http://www.thelancet.com/search/results?fieldName=Authors&searchTerm=Ana+Graf>
 MD d<http://www.thelancet.com/journals/laneur/article/PIIS1474-4422(12)70140-0/fulltext#aff4>
Immunotherapy targeting the amyloid β (Aβ) peptide is a potential strategy
to slow the progression of Alzheimer's disease. We aimed to assess the
safety and tolerability of CAD106, a novel active Aβ immunotherapy for
patients with Alzheimer's disease, designed to induce N-terminal
Aβ-specific antibodies without an Aβ-specific T-cell response.
We did a phase 1, double-blind, placebo-controlled, 52-week study in two
centres in Sweden. Participants, aged 50--80 years, with mild-to-moderate
Alzheimer's disease were entered into one of two cohorts according to time
of study entry and then randomly allocated (by use of a computer-generated
randomisation sequence) to receive either CAD106 or placebo (4:1; cohort
one received CAD106 50 μg or placebo, cohort two received CAD106 150 μg or
placebo). Each patient received three subcutaneous injections. All
patients, caregivers, and investigators were masked to treatment allocation
throughout the study. Primary objectives were to assess the safety and
tolerability of CAD106 and to identify the Aβ-specific antibody response.
Safety assessment was done by recording of all adverse events, assessment
of MRI scans, physical and neurological examinations, vital signs,
electrocardiography, electroencephalography, and laboratory analysis of
blood and CSF. Patients with Aβ-IgG serum titres higher than 16 units at
least once during the study were classified as responders. This study is
registered with ClinicalTrials.gov <http://clinicaltrials.gov/>, number
NCT00411580 <http://clinicaltrials.gov/ct2/show/NCT00411580>.
Between August, 2005, and March, 2007, we randomly allocated 31 patients
into cohort one (24 patients to CAD106 treatment and seven to placebo) and
27 patients into cohort two (22 patients to CAD106 treatment and five to
placebo). 56 of 58 patients reported adverse events. In cohort one,
nasopharyngitis was the most commonly reported adverse event (10 of 24
CAD106-treated patients). In cohort two, injection site erythema was the
most commonly reported adverse event (14 of 22 CAD106-treated patients).
Overall, nine patients reported serious adverse events--none was thought to
be related to the study drug. We recorded no clinical or subclinical cases
of meningoencephalitis. 16 of 24 (67%) CAD106-treated patients in cohort
one and 18 of 22 (82%) in cohort two developed Aβ antibody response meeting
pre-specified responder threshold. One of 12 placebo-treated patients (8%)
had Aβ-IgG concentrations that qualified them as a responder.
Our findings suggest that CAD106 has a favourable safety profile and
acceptable antibody response in patients with Alzheimer's disease. Larger
trials with additional dose investigations are needed to confirm the safety
and establish the efficacy of CAD106.
Novartis Pharma AG.

Best regards,

James Clement
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