ClinicalTrials.Veeva

Menu

Meaningful Aspects of Health for Adults With Dementia, Their Care Partners and Healthcare Practitioners (DiME)

C

Centre Hospitalier Universitaire de Nice

Status

Withdrawn

Conditions

Alzheimer Disease

Treatments

Other: Survey

Study type

Observational

Funder types

Other

Identifiers

NCT06242574
23-PP-11

Details and patient eligibility

About

The aim of this study is to describe, using a non-interventional survey, the relevant aspects of health in adults with ADRD for the patients themselves, their carers and healthcare professionals. Commonalities and differences between these three stakeholders and according to the severity of the dementia will also be studied.

Full description

Alzheimer's disease and related disorders (ADRD) are the sixth leading cause of death among adults. Currently, more than 55 million people worldwide are living with the disease, with nearly 10 million new cases each year. ADRD causes significant economic and care burdens for thousands of families and their communities, with over 60% of caregivers developing depressive symptoms. ADRD is ranked among the most costly diseases for society . It is therefore necessary to intervene in order to combat this devastating disease. As recent guidance from the Food and Drug Administration indicates, there is a need to identify areas and mechanisms for real-world change to improve patients' quality of life.

The European Medicines Agency Expert Advisory Group concluded that there was no consensus on validated outcomes in early-stage ADRD and identified the need to fill these gaps.

To demonstrate the utility of any clinical outcome assessment, it's important to link these measures to real-world experiences. And to create this link, research is needed to better understand the meaningful aspects of the health of Alzheimer's patients and their caregivers. In addition, it is important to understand how these MAHs relate to clinicians' perspectives and their approach to assessing disease severity.

Thus, the aim of this study is to describe, using a non-interventional survey, the relevant aspects of health in adults with ADRD for the patients themselves, their carers and healthcare professionals.

Participants with Alzheimer's disease and related dementia and caregivers will be recruited through the Memory Clinic at the Geriatric Hospital in Nice.

Healthcare practitioners working at Centre de Mémoire de Ressources et de Recherche, or outside the Centre , and actively treating a minimum of 10 adults with ADRD, including: neurologists, geriatricians, psychiatrists, neuropsychologists and social workers will be proposed to participate.

All participants will be given a web link to access the survey and will complete it remotely. The survey will take approximately 30 minutes to complete.

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Adults with Alzheimer's disease and related dementia:

  1. ADRD inclusive of the following :

    • Mild dementia due to Alzheimer's disease inclusive of:

      • Mild Cognitive Impairment (MCI),
      • Prodromal Alzheimer's disease,
      • Subjective cognitive impairment,
      • Early onset dementia due to Alzheimer's disease,
      • Mild Alzheimer's Disease
    • Frontotemporal dementia (FTD) - Frontal variant

    • Frontotemporal dementia (FTD) - Primary progressive aphasia

    • Lewy Body dementia (LBD)

    • Vascular dementia

  2. Ability to read, understand and express non opposition

  3. Aged 50 years or older

  4. Patient affiliated to the social security system

Care partners:

  1. Unpaid care partners for adults with Alzheimer's disease and related dementia

    ■ A care partner is the primary person who cares for an adult with ADRD, including but not limited to partner, spouse, family member, or significant other of the individual with ADRD. Care partners will be recruited where they care for patients with:

    • Mild dementia due to Alzheimer's disease (inclusive of Mild Cognitive Impairment (MCI), Prodromal Alzheimer's disease, Subjective cognitive impairment, Early onset dementia due to Alzheimer's disease, Mild Alzhiemer's Disease )
    • Moderate to severe dementia due to Alzheimer's disease
    • Frontotemporal dementia (FTD) - Frontal variant
    • Frontotemporal dementia (FTD) - Primary progressive aphasia
    • Lewy Body dementia (LBD)
    • Vascular dementia
  2. Delivers at least 10 hours of additional care per week since diagnosis

  3. Ability to read, understand and express non opposition

  4. Aged 18 years or older

  5. Subject affiliated to the social security system

Health-care practitioners

  1. Healthcare practitioners actively treating adults with ADRD, including: neurologists, geriatricians, psychiatrists, neuropsychologists and social workers
  2. Currently treats a minimum of 10 ADRD patients
  3. express non opposition

Trial design

0 participants in 3 patient groups

Adults with Alzheimer's disease and related dementia
Description:
75 patients with ADRD
Treatment:
Other: Survey
Care partners of Adults with Alzheimer's disease and related dementia
Description:
75 care partners for adults with ADRD
Treatment:
Other: Survey
Clinicians who treat patients with Alzheimer's disease and related dementia
Description:
25 healthcare practitioners
Treatment:
Other: Survey

Trial contacts and locations

1

Loading...

Central trial contact

Justine LEMAIRE; Guillaume SACCO, MD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems