Mild Cognitive ImpairmentDARENCT07504965
Dementia-friendly Apothecaries as a Resource for Mental Heath in the Elderly
An observational study of Mild Cognitive Impairment and Mild Dementia, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment, Mild Dementia
- How many people
- 1,020 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jul 2025to 31 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Department of Psychiatry and Psychotherapy, LMU Hospital
Munich, Bavaria, 80336
Carolin I Kurz, M.D., psy.alzheimerzentrum@med.uni-muenchen.de
About this study
Official title: 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.
Read the 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:
- 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.
- Conditions
- Mild Cognitive Impairment, Mild Dementia
- Keywords
- Dementia-friendly pharmacies, Cognitive impairment, Early detection, Accessible healthcare, Digital cognitive assessments, Prevention of dementia
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2025 - 2027
Secondary outcomes (2)
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
Measured: 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
Measured: 2025 - 2027
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2026
- Study start1 Jul 2025
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,020 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- Bayerisches Staatsministerium für Gesundheit, Pflege und Prävention
- Responsible party
- Principal investigator, Carolin Kurz, Ludwig-Maximilians - University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07504965
- Sponsor's protocol ID
- 24-0345
- Other IDs
- 3565-48
- Acronym
- DARE
- Status last verified
- Mar 2026
- First submitted
- 26 Nov 2024
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Demenz-freundliche Apotheken Als Ressource für Psychische Gesundheit im Alter
- ClinicalTrials.gov ID
- NCT07504965
- Acronym / sponsor ID
- DARE / 24-0345
- Conditions
- Mild Cognitive Impairment, Mild Dementia
- Keywords
- Dementia-friendly pharmacies, Cognitive impairment, Early detection, Accessible healthcare, Digital cognitive assessments, Prevention of dementia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,020 participants (estimated)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Collaborators
- Bayerisches Staatsministerium für Gesundheit, Pflege und Prävention
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 1 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
Healthcare utilization: number of healthcare contacts
Time frame: 2025 - 2027
Proportion of participants with new diagnosis of cognitive or neurological disorder
Time frame: 2025 - 2027
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mild Cognitive Impairment and Mild Dementia, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carolin I Kurz, M.D. (+498944005863, psy.alzheimerzentrum@med.uni-muenchen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in WHOQOL-BREF psychological domain score (time frame: 2025 - 2027). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.