Evidence map›Paper›PMID 38567735›Full record

Trial reportAlzheimer's & dementia : the journal of the Alzheimer's Association2024

Results from the long-term extension of PRIME: A randomized Phase 1b trial of aducanumab.

Tianle Chen, John O'Gorman, Carmen Castrillo-Viguera, Rajasimhan Rajagovindan, Gioacchino G Curiale, Ying Tian, Dakshaben Patel, Philipp von Rosenstiel, Christian von Hehn, Stephen Salloway and 5 more

Open access · hybridAbstract readRandomized Controlled TrialClinical Trial, Phase I
In one paragraph

Trial report in Alzheimer's & dementia : the journal of the Alzheimer's Association, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 1 pooled it
5.6field-weighted citation impact, top 3% 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

17 citing papers in PubMed, 1 synthesis or guideline pooled it, 17 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Results from the long-term extension of PRIME: A randomized Phase 1b trial of aducanumab.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2024
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  10. The evolving landscape of amyloid-targeting therapies in Alzheimer's disease: progress and challenges.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2026
    Review
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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

15 authors at 4 institutions in 3 countries.

Tianle ChenBiogen, Cambridge, Massachusetts, USA.
John O'GormanBiogen, Cambridge, Massachusetts, USA.ORCID 0000-0001-6549-4038
Carmen Castrillo-VigueraBiogen, Cambridge, Massachusetts, USA.
Rajasimhan RajagovindanBiogen, Cambridge, Massachusetts, USA.
Gioacchino G CurialeBiogen, Cambridge, Massachusetts, USA.
Ying TianBiogen, Cambridge, Massachusetts, USA.
Dakshaben PatelBiogen, Innovation House, Maidenhead, UK.
Philipp von RosenstielBiogen, Cambridge, Massachusetts, USA.
Christian von HehnBiogen, Cambridge, Massachusetts, USA.
Stephen SallowayButler Hospital, Providence, Rhode Island, USA.
Christoph HockNeurimmune, University of Zürich, Zürich, Switzerland.
Roger M NitschNeurimmune, University of Zürich, Zürich, Switzerland.
Samantha Budd HaeberleinBiogen, Cambridge, Massachusetts, USA.
Alfred SandrockBiogen, Cambridge, Massachusetts, USA.
Priya SinghalBiogen, Cambridge, Massachusetts, USA.
Biogen (United States) · USUniversity of Zurich · CHBiogen (United Kingdom) · GBProvidence College · US

Funding

Biogen Inc. NCT01677572
6 · The paper itself

Abstract

introductionAducanumab selectively targets aggregated forms of amyloid beta (Aβ), a neuropathological hallmark of Alzheimer's disease (AD).

methodsPRIME was a Phase 1b, double-blind, randomized clinical trial of aducanumab. During the 12-month placebo-controlled period, participants with prodromal AD or mild AD dementia were randomized to receive aducanumab or placebo. At week 56, participants could enroll in a long-term extension (LTE), in which all participants received aducanumab. The primary endpoint was safety and tolerability.

resultsAmyloid-related imaging abnormalities-edema (ARIA-E) were the most common adverse event. Dose titration was associated with a decrease in the incidence of ARIA-E. Over 48 months, aducanumab decreased brain amyloid levels in a dose- and time-dependent manner. Exploratory endpoints suggested a continued benefit in the reduction of clinical decline over 48 months. DISCUSSION: The safety profile of aducanumab remained unchanged in the LTE of PRIME. Amyloid plaque levels continued to decrease in participants treated with aducanumab. HIGHLIGHTS: PRIME was a Phase 1b, double-blind, randomized clinical trial of aducanumab. We report cumulative safety and 48-month efficacy results from PRIME. Amyloid-related imaging abnormalities-edema (ARIA-E) were the most common adverse event (AE); 61% of participants with ARIA-E were asymptomatic. Dose titration was associated with a decrease in the incidence of ARIA-E. Aducanumab decreased levels of amyloid beta (Aβ) in a dose- and time-dependent manner.

Indexed as

Alzheimer DiseaseAmyloid beta-PeptidesAntibodies, Monoclonal, HumanizedAgedBrainDose-Response Relationship, DrugDouble-Blind MethodFemaleHumansMalePlaque, AmyloidTreatment OutcomeAmyloid beta-PeptidesAntibodies, Monoclonal, HumanizedaducanumabAlzheimer's diseaseamyloid‐related imaging abnormalitiesclinical trialsPRIME

Identifiers

PMID38567735
PMCPMC11095417
OpenAlexW4393850203

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.