Reference information for collaborators using 100-plus Study data or biological materials.

The 100-plus Study is a prospective longitudinal cohort study based at Amsterdam UMC, Amsterdam, the Netherlands. The study investigates factors associated with maintained cognitive health during extreme aging and includes cognitively healthy centenarians, their first-degree family members and partners. The study was initiated in 2013 and participants are followed longitudinally. For a detailed description of the original cohort, study design and data collection, please refer to our cohort paper:

The 100-plus Study of cognitively healthy centenarians: rationale, design and cohort description. Holstege H,
Beker N, Dijkstra T, Pieterse K, Wemmenhove E, Schouten K, Thiessens L, Horsten D, Rechtuijt S, Sikkes S, van Poppel
FWA, Meijers-Heijboer H, Hulsman M, Scheltens P. Eur J Epidemiol. 2018 Dec;33(12):1229 1249. doi: 10.1007/s10654-018-0451-3. Epub 2018 Oct 25. PMID: 30362018; PMCID: PMC6290855

Ethical approval and study registration

The 100-plus Study was initiated in 2013 under non-WMO protocol 2013/82. The study was subsequently expanded under the Dutch Medical Research Involving Human Subjects Act (WMO) and received approval from the Medical Ethics Review Committee of VU University Medical Center, now Amsterdam UMC. The main regulatory identifiers for the study are:

METC study registration number: 2016.440 Dutch national study number: NL57750.029.17 OHRP IRB registration of reviewing committee: IRB00002991 Institutional Federalwide Assurance (FWA): FWA00017598 Principal Investigator: Henne Holstege, PhD Sponsor: Amsterdam UMC

The study received approval under Medical Ethics Review Committee (METC) registration number 2016.440 / NL57750.029.17. The reviewing committee is registered with the US Office for Human Research Protections (OHRP) with registration number IRB00002991, and the institutional Federalwide Assurance number is FWA00017598. [English IRB approval (2017)]

Biobanking

Biological materials collected within the 100-plus Study are maintained within the 100-plus Study Biobank at Amsterdam UMC. The establishment of the biobank received formal approval from the VUmc Biobank Review Committee and is linked to WMO study 2016.440.

Biobank registration number: 2017.122 [100-plus Study Biobank approval (2017)]

What is collected in the 100-plus Study?

The 100-plus Study collects extensive longitudinal phenotypic and biological information. Depending on the participant and the optional study components for which consent has been provided, this includes:

• demographic, genealogical, lifestyle, socioeconomic and medical information; • longitudinal neuropsychological and general health assessments; • blood samples for genetic, biomarker, immunological and other molecular analyses; • physical measurements, including blood pressure and grip strength; • optional fecal samples for microbiome studies; • optional generation of induced pluripotent stem cells (iPSCs); • optional brain imaging; • and post-mortem brain donation.

The current protocol describes collection of lifestyle, genealogy, neuropsychological, medical and socioeconomic data, blood, physical measurements, brain tissue, imaging and annual follow-up of cognitive functioning and general health.

Post-mortem brain donation:

Post-mortem brain donation within the 100-plus Study is organised by the 100-plus Study, with the Netherlands Brain Bank (NBB) providing services for the post-mortem donation procedure, autopsy and tissue processing. The associated procedures are performed under NBB/VUmc-METC protocol 2009/148. Brain tissue donated by participants of the 100-plus Study forms part of the 100-plus Study brain collection and is not part of the general NBB collection.

Suggested ethics statement for publications

Ethics statement

The 100-plus Study was approved by the Medical Ethics Review Committee of VU University Medical Center, now Amsterdam UMC (METC registration number 2016.440; national study number NL57750.029.17). The reviewing committee is registered with the US Office for Human Research Protections (IRB00002991), and the institutional Federalwide Assurance number is FWA00017598. All participants provided informed consent for participation and the use and sharing of their coded data and biological materials for scientific research. The 100-plus Study Biobank was approved under registration number 2017.122.

For studies using post-mortem brain tissue, add: Post-mortem brain donation procedures were carried out using services provided by the Netherlands Brain Bank under protocol 2009/148; the resulting brain tissues form part of the 100-plus Study brain collection.

Ethics and regulatory documents

The following documents are provided for collaborators requiring documentation of ethical and biobank approval: