Evidence map›Paper›PMID 28124589›Full record

Trial reportCurrent Alzheimer research2017

Long-Term Extensions of Randomized Vaccination Trials of ACC-001 and QS-21 in Mild to Moderate Alzheimer's Disease.

Michael Hull, Carl Sadowsky, Heii Arai, Ghislaine Le Prince Leterme, Ann Holstein, Kevin Booth, Yahong Peng, Tamotsu Yoshiyama, Hideo Suzuki, Nzeera Ketter and 2 more

Open access · bronzeAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Current Alzheimer research, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 40 papers.

0numbers the graph read from it
0cells of the map it votes in
40citing papers in PubMed
3.0field-weighted citation impact, top 9% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

40 citing papers in PubMed, 60 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 7 institutions in 4 countries.

Michael HullClinic for Geriatric Psychiatry, Center for Psychiatry Emmendingen, Neubronnstraße 25, D-79312 Emmendingen. Germany.
Carl SadowskyPremiere Research Institute, Palm Beach Neurology, Nova SE University, 4631 North Congress Ave., Suite 200, West Palm Beach, FL 33407, United States.
Heii AraiDepartment of Psychiatry & Behavioral Science, Juntendo University Graduate School of Medicine, 2-1-1 Hongo, Bunkyo-ku, Tokyo 113-0033, Japan.
Ghislaine Le Prince LetermePfizer Global Research and Development, 23-25 avenue du Docteur Lannelongue, 75668 Paris cedex 14. France.
Ann HolsteinPfizer Inc., 500 Arcola Road, Collegeville, PA 19426, United States.
Kevin BoothPfizer Inc., 500 Arcola Road, Collegeville, PA 19426, United States.
Yahong PengPfizer Inc., 500 Arcola Road, Collegeville, PA 19426, United States.
Tamotsu YoshiyamaPfizer Japan Inc., 3-22-7 Yoyogi, Shibuya-ku, Tokyo 151- 8589, Japan.
Hideo SuzukiPfizer Japan Inc., 3-22-7 Yoyogi, Shibuya-ku, Tokyo 151- 8589, Japan.
Nzeera KetterJanssen Research and Development, 3210 Merryfield Row, San Diego, CA 92121, United States.
Enchi LiuJanssen Research and Development, 3210 Merryfield Row, San Diego, CA 92121, United States.
J Michael RyanPfizer Inc., 500 Arcola Road, Collegeville, PA 19426, United States.
Pfizer (United States) · USJanssen (United States) · USPfizer (Japan) · JPJuntendo University · JPPfizer (France) · FRPremiere Research Institute · USZentrum für Psychiatrie Emmendingen · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesLong-term safety and tolerability of ACC-001 (vanutide cridificar), an antiamyloid- beta therapeutic vaccine, was evaluated in subjects with mild to moderate Alzheimer's disease.

designPhase 2a extension studies of randomized parent trials were conducted in the United States, European Union, and Japan.

methodsFour immunizations of ACC-001 were administered at the same 3 dose levels (3, 10, and 30 μg) to subjects randomized in the parent studies; ACC-001 was administered with QS-21 adjuvant. Safety, tolerability, and immunogenicity were assessed during active treatment and 6-month follow-up.

resultsACC-001 + QS-21 was well tolerated in the United States (N=110) and European Union (N=50), and Japan (N=53) extension studies; safety profile was similar to that observed in the parent studies, and no new safety signals were identified. Overall, injection site reactions were the most common adverse event in these studies. Anti-amyloid antibody titers were elicited in all groups, with the highest titers observed in subjects who received ACC-001 + QS-21 in both the parent and extension studies.

conclusionsLong-term exposure to ACC-001 + QS-21 was well tolerated in subjects with Alzheimer's disease, suggesting that side effects do not pose a principal limitation for anti-amyloid active immunotherapy. The highest anti-amyloid-beta IgG titers are elicited during long-term therapy with ACC-001 + QS-21 compared with other regimens.

Indexed as

AgedAged, 80 and overAlzheimer DiseaseAmyloid beta-PeptidesDose-Response Relationship, ImmunologicEuropeFemaleHumansInternational CooperationJapanLongitudinal StudiesMaleMental Status ScheduleMiddle AgedRecombinant Fusion ProteinsSaponinsAmyloid beta-PeptidesRecombinant Fusion Proteinssaponin QA-21V1Saponinsvanutide cridificarAlzheimer’s diseaseamyloid-betaamyloid plaquesantibodyimmunotherapyvaccine

Identifiers

PMID28124589
PMCPMC5543567
OpenAlexW2585057996

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.