German Dementia Registry (DEMREG)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study topic, other:
  Dementia, Registry, Biomarkers, Neurodegeneration, Natural history, Treatment, Mild cognitive impairment
• Study type:
  Not applicable
• Scope of the study:
  Disease epidemiology

  Drug utilisation

  Evaluation of patient-reported outcomes
• If ‘Not applicable’, further details on the study type:
  The study is a registered open-ended prospective registry
• Data collection methods:
  Combined primary data collection and secondary use of data

Study drug and medical condition

• Medicinal product name:
  LEQEMBI
• Medicinal product name, other:
  Donanemab - Kisunla®
• Study drug International non-proprietary name (INN) or common name:
  LECANEMAB
• Anatomical Therapeutic Chemical (ATC) code:
  (N06DX05) donanemab

  donanemab
• Medical condition to be studied:
  Dementia

  Cognitive disorder

Population studied

• Short description of the study population:
  Participating patients must have a level of cognitive decline of SCD, MCI or early dementia with a clinical diagnosis of i.e. Alzheimer’s Disease, Frontotemporal Dementia, Parkinson’s Disease, Lewy-Body Dementia, Progressive Supranuclear Palsy, Corticobasal Degeneration, Normal Pressure Hydrocephalus, Major Depression; Vascular Dementia; TDP-43 associated limbic encephalopathy (LATE), Mixed Dementia AD + VaD, Prion Associated Dementia together with biomarkers such as cerebrospinal fluids (CSF) amyloid beta 1-42, amyloid beta 1-40, amyloid beta 1-42/amyloid beta 1-40 ratio, total tau and phosphorylated tau, amyloid or tau imaging.
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Cognitive impairment
• Estimated number of subjects:
  5000

Study design details

• Study design:
  This is an open-ended prospective longitudinal multicenter registry in adult patients with SCD, MCI or early dementia of different etiology with fluid biomarkers such as cerebrospinal fluids (CSF).
• Main study objective:
  The primary goal of the DEMREG is to establish a register for the collection of data and biomarkers related to amyloid-beta (Aβ) and tau pathology of cognitive impairment and early dementia in Germany. This also includes patients with anti-amyloid or other treatments.; The central task of the DEMREG is to systematically collect longitudinal data on demographics, clinical and neuropsychological characteristics, as well as imaging, blood, and cerebrospinal fuid markers in patients with subjective cognitive decline (SCD), mild cognitive impairment (MCI) or mild dementia to measure the natural course and therapeutic effects.; It is designed to investigate the natural course of cognitive disorders, while also capturing the effects of therapeutic interventions and identifying risk factors that may infuence disease progression. By integrating longitudinal clinical, biomarker, and treatment data from clinical routine, the registry aims to uncover patterns that contribute to a better understanding of disease dynamics. Ultimately, the fndings are intended to support the development of targeted strategies to improve patient care and optimize treatment pathways.
• Setting:
  All memory clinics within the German Network of Memory Clinics (Deutsches Netzwerk Gedächtnisambulanzen [DNG]; www.gedaechtnisambulanzen.de) are eligible to participate in this registry.; Patients are eligible as participants if: (a) they (or their legally authorized representative) are able to understand the purpose and risks of the registry and provide written informed consent and authorization to use protected health information in accordance with national and local privacy regulations; (b) they have received a diagnosis of subjective cognitive decline (SCD), mild ; cognitive impairment (MCI), or mild dementia, irrespective of etiology; (c) they have available results of neurodegeneration biomarkers (i.e., cerebrospinal fuid (CSF) Aβ1-42, Aβ1-40, Aβ1-42/Aβ1-40 ratio, total tau, and phosphorylated tau, and/or Aβ-PET or tau- PET imaging); and ; (d) they are 18 years of age or older. ; Study partners are eligible if: (a) they are 18 years of age or older, (b) they are study partners of a patient who has been included in the registry, (c) they have regular contact with the patient (according to the patient’s statement), and (d) they can understand the purpose and risks of participating in the study and provide written informed consent.; ; Most of the data (e.g. demographics, medical history, medication, cognitive assessments) are collected from routine clinical records. Additional diagnostic parameters, such as biomarkers, imaging and laboratory results, will also be documented if they are available as art of the clinical routine. Existing neuropsychological data from routine clinical assessments that are no older than six months will also be included. If consented to, blood samples will be collected for biobank storage. Follow-up visits are conducted on an annual basis (±3 months).
• Data analysis plan:
  The registry’s primary goal is to evaluate current diagnostic and treatment practices in terms of their efectiveness and infuence on disease progression, and to monitor the natural course of disease progression in a cohort of patients with cognitive impairment and dementia in Germany. The statistical analysis plan (SAP) includes an initial analysis of baseline characteristics of a German memory clinics’ cohort, which will be primarily descriptive, and with larger datasets enabling advanced statistical methods—such as linear mixed-efects models to assess progression rates and the validity of outcomes (e.g. responsiveness) on longitudinal assessments. Continuous variables will be reported using measures like mean, standard deviation, range, and quantiles, with categorical data presented as counts and percentages of valid responses. ; The study evaluates real-world data regarding treatment effectiveness and ARIA management.