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NCT Number: NCT07504965

Dementia-friendly Apothecaries as a Resource for Mental Heath in the Elderly

The DARE study (Dementia-Friendly Apothecaries as a Resource for Mental Health in the Elderly) is a multicenter, prospective cohort study aiming to identify individuals with cognitive impairments early in pharmacies and enhance their access to support services. Partner pharmacies are equipped with memory test stations, and pharmaceutical staff are trained to guide participants. The digital memory test evaluates cognitive, psychosocial, and health factors, displaying results in a traffic light graphic. Participants with concerning results are referred to specialists or support services.

The study's primary goals are to establish pharmacies as dementia screening hubs, improve care for affected individuals, promote interdisciplinary collaboration, and lay the groundwork for legal and billing frameworks. An optional subproject validates the screening through neurological evaluations.

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Key information

Age range

60 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Psychiatry and Psychotherapy, LMU Hospital

Munich, Bavaria, 80336, Germany

Location status: Recruiting

Location contact

Carolin I Kurz, M.D.

CONTACT

[email protected]

About this study

The DARE study (Dementia-Friendly Apothecaries as a Resource for Mental Health in the Elderly) is a multicenter, prospective cohort initiative designed to identify individuals with early cognitive impairments through pharmacies, making healthcare and support more accessible. It targets people with initial cognitive symptoms or mild dementia and aims to promote early intervention and improve quality of life.

Key Features:

  • Screening Process: Partner pharmacies (10 across urban and rural settings) are equipped with memory test stations, including tablets for digital cognitive assessments and structured questionnaires. These cover cognitive decline, cardiovascular risk, and depression.
  • Traffic Light System: Results are displayed via a color-coded system (green, yellow, red), guiding next steps for participants, such as seeking medical consultation or accessing support services.
  • Pharmacy Staff Training: Staff receive training to communicate effectively with cognitively impaired individuals and manage the digital tools.
  • Demographic Data Collection: Information such as age, education, and marital status is gathered to understand participant profiles and tailor interventions.

Objectives:

  • Establish pharmacies as accessible hubs for dementia screening and support.
  • Evaluate the effectiveness of the screening process and its impact on participants' healthcare behavior.
  • Validate digital screening tools in non-clinical environments and explore their sensitivity and specificity.

Optional Subproject: A subset of participants undergoes additional clinical validation at the Alzheimer Therapy and Research Center, including neurological exams, imaging, and biomarker analysis.

The study emphasizes privacy through double pseudonymization, secure data handling, and adherence to ethical standards. It seeks to demonstrate the socioeconomic value of pharmacy-based dementia screening and create a framework for broader implementation.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age: Participants must be 60 years or older at the time of consent.
  • Language Proficiency: Sufficient knowledge of the German language to understand instructions and participate in the study.
  • Cognitive Status: Presence of self-reported, relative-reported, or pharmacist-identified cognitive impairments (e.g., memory problems or mild cognitive changes).
  • Consent: Ability to provide informed consent voluntarily.

Exclusion criteria

  • Severe Sensory Impairments: Participants unable to see or hear well enough to complete the digital assessments or questionnaires.
  • Previous Dementia Diagnosis: Individuals with a prior formal diagnosis of dementia, whether with or without underlying pathology.
  • Severe Cognitive or Physical Impairments: Any condition that would prevent meaningful participation in the digital tests or structured screening process.

These criteria aim to ensure that the study includes participants at risk of early cognitive decline while excluding those for whom the interventions or assessments would not be feasible or relevant.

Treatment and study plan

Primary outcomes

  1. Change in WHOQOL-BREF psychological domain score

    Time frame: 2025 - 2027

    Quality of life will be assessed using the World Health Organization Quality of Life Questionnaire, Brief Version (WHOQOL-BREF). The primary outcome is the change in the psychological domain score from baseline to 24-month follow-up. The psychological domain score will be calculated according to the WHOQOL-BREF scoring manual and transformed to a 0-100 scale, with higher scores indicating better quality of life.

    Unit of Measure

    points (0-100 scale)

    Time Frame

    Baseline and 24 months

Secondary outcomes

  1. Healthcare utilization: number of healthcare contacts

    Time frame: 2025 - 2027

    Outcome Measure Title:

    Number of healthcare contacts

    Description:

    Healthcare utilization will be assessed using a structured study-specific questionnaire administered via telephone at 12- and 24-month follow-up. The outcome will be the number of healthcare contacts within the preceding 12 months, including visits to general practitioners, medical specialists, hospital admissions, and use of support services (e.g., counseling services, memory clinics, or social support programs).

    Unit of Measure:

    Number of contacts (count)

    Time Frame:

    12 months and 24 months

  2. Proportion of participants with new diagnosis of cognitive or neurological disorder

    Time frame: 2025 - 2027

    Description:

    New diagnoses will be assessed via participant self-report during structured telephone interviews at follow-up. The outcome is defined as the proportion of participants reporting a newly established diagnosis of a cognitive or neurological disorder (e.g., mild cognitive impairment or dementia) since baseline. Where feasible, diagnoses will be verified through available clinical documentation.

    Unit of Measure:

    Percentage of participants (%)

    Time Frame:

    12 months and 24 months

Study contacts

Contact information is provided by the study sponsor or research team.

Carolin I Kurz, M.D.

CONTACT

[email protected]

+498944005863

Sponsors and collaborators

Lead sponsor

Ludwig-Maximilians - University of Munich

Other

Collaborators

  • Bayerisches Staatsministerium für Gesundheit, Pflege und Prävention

Registry information

Official study title

Demenz-freundliche Apotheken Als Ressource für Psychische Gesundheit im Alter

Acronym: DARE

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 1, 2026
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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