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

Demenz-freundliche Apotheken Als Ressource für Psychische Gesundheit im Alter

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.

Study Overview

• Status: Recruiting
• Conditions: Mild Cognitive Impairment; Mild Dementia

Detailed Description

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:

1. Establish pharmacies as accessible hubs for dementia screening and support.
2. Evaluate the effectiveness of the screening process and its impact on participants' healthcare behavior.
3. 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.

• Study Type: Observational
• Enrollment (Estimated): 1020

Contacts and Locations

• Study Contact: Name: Carolin I Kurz, M.D.; Phone Number: +498944005863; Email: psy.alzheimerzentrum@med.uni-muenchen.de

Study Locations

• Germany
  • Bavaria
    • Munich, Bavaria, Germany, 80336
      • Recruiting
      • Department of Psychiatry and Psychotherapy, LMU Hospital
      • Contact: Carolin I Kurz, M.D.; Email: psy.alzheimerzentrum@med.uni-muenchen.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Study Population:

The study population consists of individuals aged 60 and older, recruited from urban and rural pharmacies. Participants include those with self-reported, relative-reported, or pharmacist-identified cognitive impairments ranging from initial symptoms to mild dementia. The cohort emphasizes diversity, capturing various demographic factors such as migration background, education level, marital status, and living situations, with a focus on underrepresented and underserved groups, including isolated individuals and those in rural areas.

Description

Inclusion Criteria

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

Exclusion Criteria

1. Severe Sensory Impairments: Participants unable to see or hear well enough to complete the digital assessments or questionnaires.
2. Previous Dementia Diagnosis: Individuals with a prior formal diagnosis of dementia, whether with or without underlying pathology.
3. 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

prospective cohort study; The study cohort for the DARE project includes customers and patients from pharmacies located in both urban and rural areas. These participants represent a diverse population segment, including individuals who might not regularly access traditional healthcare services, particularly in rural regions where medical facilities are less accessible. Cohort Details: Eligibility Criteria:Age: 60 years and older.Cognitive impairments noted by participants themselves, relatives, or pharmacy staff.Sufficient understanding of the German language.; Inclusion Focus:Individuals with early cognitive symptoms or mild dementia.Those potentially underserved by conventional healthcare systems, such as isolated or single individuals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in WHOQOL-BREF psychological domain score	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	2025 - 2027

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healthcare utilization: number of healthcare contacts	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	2025 - 2027
Proportion of participants with new diagnosis of cognitive or neurological disorder	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	2025 - 2027

Collaborators and Investigators

• Sponsor: Ludwig-Maximilians - University of Munich
• Collaborators: Bayerisches Staatsministerium für Gesundheit, Pflege und Prävention

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2025
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027

Study Registration Dates

• First Submitted: November 26, 2024
• First Submitted That Met QC Criteria: March 26, 2026
• First Posted (Actual): April 1, 2026

Study Record Updates

• Last Update Posted (Actual): April 1, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Cognitive impairment; Early detection; Prevention of dementia; Accessible healthcare; Dementia-friendly pharmacies; Digital cognitive assessments
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: 24-0345; 3565-48 (Other Grant/Funding Number: Bayerisches Staatsministerium für Gesundheit, Pflege und Prävention & soziale und private Pflegeversicherungen)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No