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A proof of concept phase II study with the PDE-4 inhibitor roflumilast in patients with mild cognitive impairment or mild Alzheimer’s disease dementia (ROMEMA): study protocol of a double-blind, randomized, placebo-controlled, between-subjects trial

Crossref DOI link: https://doi.org/10.1186/s13063-024-08001-3

Published Online: 2024-03-04

Update policy: https://doi.org/10.1007/springer_crossmark_policy

Authors

Possemis, Nina

Verhey, Frans

Prickaerts, Jos

Blokland, Arjan

Ramakers, Inez
Funding

Funding for this research was provided by:

ZonMw
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Text and Data Mining valid from 2024-03-04

Version of Record valid from 2024-03-04
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Article History

Received: 27 December 2023

Accepted: 21 February 2024

First Online: 4 March 2024

Declarations

:

: The MREC of MUMC+ approved the trial (registration number MREC 20-021). The study will be conducted according to the principles of the Declaration of Helsinki (World Medical Association, October 2013) and in accordance with the Dutch Medical Research Involving Human Subjects Act (Dutch: WMO). All participants will provide written informed consent prior to participation.

: Not applicable.

: AB and JP have proprietary interest in the PDE4 inhibitor roflumilast.

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