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

NCT07504965 | Recruiting

• 2 other identifiers: 24-03453565-48
• Study Type: observational
• Target: 1,020
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mild Cognitive Impairment; Mild Dementia

Keywords

Dementia-friendly pharmacies; Cognitive impairment; Early detection; Accessible healthcare; Digital cognitive assessments; Prevention of dementia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Healthcare utilization: number of healthcare contacts

  2025 - 2027

• Proportion of participants with new diagnosis of cognitive or neurological disorder

  2025 - 2027

Study Arms (1)

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: 1. Eligibility Criteria: * Age: 60 years and older. * Cognitive impairments noted by participants themselves, relatives, or pharmacy staff. * Sufficient understanding of the German language. 2. Inclusion Focus: * Individuals with early cognitive symptoms or mild dementia. * Those potentially underserved by conventional healthcare systems, such as isolated or single individuals.

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Department of Psychiatry and Psychotherapy, LMU Hospital

Munich, Bavaria, 80336, Germany

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Carolin I Kurz, M.D.

CONTACT

+498944005863; psy.alzheimerzentrum@med.uni-muenchen.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med. Carolin Kurz

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: April 1, 2026
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: April 1, 2026

Record last verified: 2026-03

Locations

DE (1)