Evidence map›Paper›PMID 32211506›Full record

ArticleAlzheimer's & dementia (New York, N. Y.)2020

Safety and pharmacokinetics of the orally available antiprionic compound PRI-002: A single and multiple ascending dose phase I study.

Janine Kutzsche, Dagmar Jürgens, Antje Willuweit, Knut Adermann, Carola Fuchs, Stefanie Simons, Manfred Windisch, Michael Hümpel, Wolfgang Rossberg, Michael Wolzt and 1 more

Abstract read
In one paragraph

Article in Alzheimer's & dementia (New York, N. Y.), 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 33 papers.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed
–field-weighted citation impact
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

33 citing papers in PubMed.

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  10. The N-type calcium channel rises from the ashes.The Journal of clinical investigation · 2025
    Article
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  16. Conformational inhibitors of protein aggregation.Current opinion in structural biology · 2023
    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

11 authors.

Janine KutzscheStructural Biochemistry (ICS-6) Institute of Complex Systems Jülich Germany.
Dagmar JürgensStructural Biochemistry (ICS-6) Institute of Complex Systems Jülich Germany.
Antje WilluweitMedical Imaging Physics (INM-4) Institute of Neuroscience and Medicine Jülich Germany.
Knut AdermannChemical & Pharmaceutical Consulting Hannover Germany.
Carola FuchsDepartment of Clinical Pharmacology Medical University of Vienna Vienna Austria.
Stefanie SimonsStructural Biochemistry (ICS-6) Institute of Complex Systems Jülich Germany.
Manfred WindischNeuroScios GmbH Graz Austria.
Michael HümpelKAIROSmetics UG Berlin Germany.
Wolfgang RossbergConsultWMR Potsdam Germany.
Michael WolztDepartment of Clinical Pharmacology Medical University of Vienna Vienna Austria.
Dieter WillboldStructural Biochemistry (ICS-6) Institute of Complex Systems Jülich Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionPRI-002 is an orally available anti-amyloid beta (Aβ) prionic compound developed for direct disassembly of toxic Aβ oligomers relevant to Alzheimer's disease.

methodsTwo placebo-controlled clinical phase I trials with oral dosing of PRI-002 were conducted in healthy young subjects: A single ascending dose trial (4, 12, 36, 108, or 320 mg PRI-002 or placebo) in 40 participants followed by a multiple ascending dose study with daily 160 mg PRI-002 for 14 days or 320 mg for 28 days in 24 participants. The main objectives were safety, tolerability, and evaluation of pharmacokinetic (PK) parameters.

resultsPRI-002 was safe and well tolerated after single and multiple oral administration up to the highest doses. PRI-002 was absorbed rapidly and drug exposure increased proportional to dose. During repeated daily administration, the drug accumulated by a factor of about three. Steady-state conditions were reached after 1 to 2 weeks.

conclusionsThe safety and PK results encourage further clinical development of PRI-002.

Indexed as

Alzheimer´s disease (AD)anti‐Aβ‐prionicfirst‐in‐human (FIH)MADmultiple ascending dosepharmacokineticsphase IPRI‐002SADsafetysingle ascending dose

Identifiers

PMID32211506
PMCPMC7087413

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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.