An interventional study of REMINDer (A digital environmental enrichment intervention) in Healthy, sponsored by German Center for Neurodegenerative Diseases (DZNE). Completed at 1 site in Germany. Open to participants aged 60 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-06.
Sponsored by German Center for Neurodegenerative Diseases (DZNE) · Not applicable, Interventional, and Other
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Among 212 studies in Alzheimer Disease with a site in Germany — 25 open to participants now, 38 under way, 17 of them phase 3. Alzheimer Disease · Germany.
Among the 212 studies in Alzheimer Disease with a site in Germany, this one is the 157th largest by enrollment of the 192 interventional ones that give a count, is one of 8 that started in 2024, is one of 25 with no phase, and was the 189th registered.
3,967 studies on the registry are indexed under Alzheimer Disease; 928 are open to participants now.
Browse Alzheimer Disease studies →25 of the 212 studies in Alzheimer Disease with a site in Germany are open now. Recruiting first, the newest first:
Sanofi · Sites in Germany, United States, Australia and 4 more countries
Ages 55–85
Exciva GmbH · Sites in Germany, United States, Canada and 6 more countries
Ages 55–90
Bristol-Myers Squibb · Sites in Germany, United States, Argentina and 23 more countries
Ages 55–90
Technical University of Munich · Sites in Germany
Ages 18+ · Healthy volunteers
NSC-Therapeutics · Sites in Germany, Austria
Ages 50–85
A study can be open while its sites in Germany have not opened yet or have stopped. Only those recruiting at a site in Germany →
Of the 642 Alzheimer Disease studies recruiting now, 283 (44%) set no upper age limit and 55 (9%) stop at 75 or younger; 34 take children under 18; 284 take healthy volunteers.
This study: 60 Years to 80 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
212 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 19 · Phase 2 73 · Phase 3 87 · Phase 4 5
First in 2002; this study’s year is marked. 8 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 58 is below the median of 70 across 3,020 interventional studies indexed under Alzheimer Disease.
Median enrollment 350 across the 192 interventional studies, 170 across the 20 observational. Of the 162 that completed or were terminated, 79 (49%) have results posted.
This tab as a report to print or save as PDF → With an account.
157 of 212 have an industry lead sponsor. The 10 most frequent:
German Center for Neurodegenerative Diseases (DZNE) is the lead sponsor of 15 studies on the registry; 2 are open to participants now.
German Center for Neurodegenerative Diseases (DZNE) has 4 studies filed under Alzheimer Disease — fewer than ten, so there is no comparison to draw.
8 of the studies in Alzheimer Disease with a site in Germany that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06585787Phase 3Karuna Therapeutics, Inc., a Bristol Myers Squibb companyA Study to Evaluate KarXT as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-4) | 2026-11-24 |
| NCT03887455Phase 3Eisai Inc.A Study to Confirm Safety and Efficacy of Lecanemab in Participants With Early Alzheimer's Disease | 2026-12-31 |
| NCT05980949Phase 3Karuna Therapeutics, Inc., a Bristol Myers Squibb companyOpen-Label Extension Study to Assess the Long-Term Safety and Tolerability of KarXT in Subjects With Psychosis Associated With Alzheimer's Disease (ADEPT-3) | 2027-09-07 |
| NCT06402838Hoffmann-La RocheA Study to Evaluate the Safety and Biomarker Effects of RO7269162 in Participants at Risk for or at the Prodromal Stage of Alzheimer's Disease (AD) | 2026-11-19 |
| NCT06544616Janssen Pharmaceutica N.V., BelgiumA Study of JNJ-64042056 in Participants With Preclinical Alzheimer's Disease | 2026-12-22 |
Add all 8 to your calendar (.ics) → With an account.
Among the 212 studies in Alzheimer Disease with a site in Germany, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The primary goal of this pilot study is to assess the feasibility and effectiveness for improving overall mental and physical well-being of a multimodal intervention program in older adults carried out in a digital telehealth setting.
Background: Increasing life expectancy and associated age-related diseases, such as Alzheimer's disease, are considered a global challenge for society. Multiple physical, cognitive, and psychosocial risk factors can increase the risk of developing Alzheimer's disease. To effectively maintain mental health and well-being in older adults, multimodal, low-threshold, cost-effective, lifestyle-based intervention strategies that simultaneously and sustainably promote cognitive, physical, psychological, and social functioning in the older population are needed.
Objective: The primary objective of this randomized, controlled pilot study is to assess the feasibility and effectiveness of a multimodal intervention program delivered in a digital telehealth environment to improve overall mental and physical well-being of older adults.
Methods: The REMINDer study is a monocentric, randomized, assessor-blinded, controlled pilot study with a 6-week intervention period (2 hours per week). The study includes a digital multimodal intervention called REMINDer (Environmental Enrichment Intervention to Prevent Dementia - electronic intervention). This program is specifically designed for older adults and includes music, dance-based movement, and mind (specifically mindfulness) activities that are simultaneously trained to activate and strengthen brain resources and resilience to dementia. The intervention will be delivered in a digital telehealth environment (via an established videoconferencing platform) and compared to a 6-week passive control (waitlist with delayed intervention, AB-BA design) in a cross-over study design. For this first pilot study, a total of n = 50 cognitively unimpaired older adults will be recruited from the general population (spouses will be allowed in the same group and analyses will be controlled accordingly). Participants will be randomized to the two intervention groups using block randomization, stratified by age and sex, with a 1:1 allocation ratio.
Results: The primary outcomes of the study are feasibility, operationalized by adherence rates, and effectiveness of the intervention. Adherence per participant will be assessed by the number of sessions attended relative to the total number of sessions. Effectiveness will be assessed by the change in self-reported overall mental and physical well-being, operationalized by the Short-Form Health Survey (SF-12), measured at baseline (t1), post-intervention (t2), and follow-up (t3). Secondary outcomes will include changes in self-reported cognitive, motor, sensory, emotional/affective, social, and lifestyle behaviors, assessed at baseline, post-intervention, and follow-up using digital assessments.
Discussion: This pilot study will provide preliminary evidence on the feasibility and effectiveness of a digital multimodal intervention (REMINDer) to improve mental health and well-being in older adults. The results of this pilot study will inform a larger intervention trial aimed at improving multiple health risk factors for dementia in older populations at increased risk for Alzheimer's disease.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Beginning with the digital multimodal intervention (REMINDer) and then transitioning to a no intervention phase (sequence: AB).
Behavioral: REMINDer (A digital environmental enrichment intervention)
Starting with a no intervention phase and subsequently moving to the digital multimodal intervention (REMINDer) (sequence: BA).
Behavioral: REMINDer (A digital environmental enrichment intervention)
REMINDer adapts the REMIND program (Nicotra et al., 2022) for telehealth, integrating cognitive, motor, sensory, emotional, and social stimulation through "music, dance-based movement, and mindfulness". The program consists of 2 online sessions/week for 60 minutes each over 6 weeks, led by trained facilitators experienced in dance movement therapy and mindfulness exercises. Sessions are divided into welcome/warm-up (10 min), training (40 min), and relaxation/feedback (10 min) phases. Using a structured manual, participants perform exercises that address the program's multimodal stimulation. The REMINDer program is delivered in a group setting via an online videoconferencing system. The "intervention, no intervention" (AB) group undergoes the training program between t1 and t2 and then resumes their normal lifestyle from t2 to t3. The "no intervention, intervention" group (BA) maintains its normal lifestyle from t1 to t2 and then participates in the training program from t2 to t3.
Feasibility: Adherence to the intervention
Assessed by the number of sessions attended in relation to the total number of sessions (\[number of sessions attended / total number of sessions\] \* 100).
Time frame: from baseline (t1) to the end of the 6-weeks intervention (t2)
Effectiveness: Change in overall mental and physical well-being
Assessed by the Short-Form-Health Survey (SF-12), range 0 to 100, higher scores indicate greater mental and physical well-being.
Time frame: from baseline (t1) to the end of the 6-weeks intervention (t2)
Feasibility: reach
\[participants enrolled / participants screened and eligible\] \* 100
Time frame: End of 6-week-intervention (t2)
Feasibility: retention rate
\[participants completing t3 / participants enrolled\] \* 100
Time frame: 12 weeks post baseline (6 weeks post intervention) (t3)
Feasibility: dropout rate
Assessed by the number of participants who did not complete the intervention and follow-up period divided by the total number of participants that underwent the randomisation process.
Time frame: a) From baseline to the end of 6-week-intervention (t2) b) From baseline to 12 weeks (t3)
Feasibility: Change in credibility and acceptance
Assessed by the Credibility Expectancy Questionnaire (CEQ), instruction adapted, range 1 to 9, higher scores indicating higher credibility and acceptance
Time frame: a) From baseline to the end of 6-week-intervention (t2) b) From baseline to 12 weeks (t3)
Change in cognitive ability: subjective cognition function
Assessed by the Everyday Cognition Scales (ECog-12), short form, instruction adapted, range 1 to 4 (mean), higher scores indicate higher subjective cognitive impairment / worse cognitive state
Time frame: a) From baseline to the end of 6-week-intervention (t2) b) From baseline to 12 weeks (t3)
Change in cognitive ability: objective cognitive function
Assessed by the Consortium to Establish a Registry for Alzheimer's Disease (CERAD): word list learning. Instruction adapted, range subscale wordlist learning 0 to 10, higher scores indicate better memory function
Time frame: a) From baseline to the end of 6-week-intervention (t2) b) From baseline to 12 weeks (t3)
Change in motor ability: frailty
Assessed by the Tilburg frailty indicator (TFI), range 0 to 15, higher scores indicate higher frailty.
Time frame: a) From baseline to the end of 6-week-intervention (t2) b) From baseline to 12 weeks (t3)
Change in sensory ability: interoceptive awareness
Assessed by the Multidimensional Assessment of Interoceptive Awareness (MAIA), subscale awareness, range 0 to 5, higher scores indicate more positive body awareness
Time frame: a) From baseline to the end of 6-week-intervention (t2) b) From baseline to 12 weeks (t3)
Change in sensory ability: self-perceived bodily abilities
Assessed by the Body Self-Efficacy Scale (BSE), range 1 to 5, higher scores indicate greater feelings associated with the four domains: guilt, shame, authentic pride and hubristic pride
Time frame: a) From baseline to the end of 6-week-intervention (t2) b) From baseline to 12 weeks (t3)
Change in well-being: psychological well-being
Assessed by the Ryff's Psychological Well-Being Scales (PWB), short form (18 items), range 1 to 7, higher scores indicate greater well-being.
Time frame: a) From baseline to the end of 6-week-intervention (t2) b) From baseline to 12 weeks (t3)
Change in well-being: general well-being
Assessed by the Heidelberg State Inventory (HSI-24), range 1 to 5, higher scores indicate higher well-being
Time frame: a) From baseline to the end of 6-week-intervention (t2) b) From baseline to 12 weeks (t3)
Change in positive emotion: life-satisfaction
Assessed by the General Life Satisfaction Short Scale (L1), range 0 to 10, higher scores indicate greater satisfaction with life
Time frame: a) From baseline to the end of 6-week-intervention (t2) b) From baseline to 12 weeks (t3)
Change in positive emotion: mindfulness
Assessed by the Freiburg Mindfulness Inventory (German: FFA), range 1 to 4, higher scores indicate more mindfulness
Time frame: a) From baseline to the end of 6-week-intervention (t2) b) From baseline to 12 weeks (t3)
Change in negative emotion: perceived stress
Assessed by the Perceived Stress Scale (PSS-10), range 1 to 5, higher scores indicate greater levels of perceived stress
Time frame: a) From baseline to the end of 6-week-intervention (t2) b) From baseline to 12 weeks (t3)
Change in negative emotion: anxiety
Assessed by the State-Trait Anxiety Inventory (STAI-5), short form, range 1 to 4, higher scores indicate higher anxiety
Time frame: a) From baseline to the end of 6-week-intervention (t2) b) From baseline to 12 weeks (t3)
Change in social integration / loneliness
Assessed by the German Version of the UCLA Three-item loneliness scale (LS-S), range 1 to 5, higher scores indicate less social integration / more loneliness
Time frame: a) From baseline to the end of 6-week-intervention (t2) b) From baseline to 12 weeks (t3)
Change in social connectedness with others
Assessed by the Inclusion of Other in the Self (IOS), range 1 to 7, higher scores indicate more overlap indicating higher social connectedness
Time frame: a) From baseline to the end of 6-week-intervention (t2) b) From baseline to 12 weeks (t3)
Change in lifestyle: social activity
Assessed by the Lubben Social Network Scale (LSNS-6), range 0 to 30, higher scores indicate bigger active and intimate networks of family and friends
Time frame: a) From baseline to the end of 6-week-intervention (t2) b) From baseline to 12 weeks (t3)
Change in lifestyle: physical activity
Assessed by the Physical Activity Scale for the Elderly (PASE), minimum score 0, higher scores indicate greater physical activity
Time frame: a) From baseline to the end of 6-week-intervention (t2) b) From baseline to 12 weeks (t3)
Change in lifestyle: sleep quality
Assessed by the Jenkins Sleep Scale 4 (JSS-4), range 0 to 20, higher scores indicate more sleep problems
Time frame: a) From baseline to the end of 6-week-intervention (t2) b) From baseline to 12 weeks (t3)
Plan to share: Undecided
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Ran from Aug 2024 to primary completion in Dec 2024, 4 months.
Of 882 non-industry interventional studies with no phase under Alzheimer Disease, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 51. This study's 4 months is below that.
Counting every sponsor, half of 959 studies reached it within 29 months; a quarter within 15 and three quarters within 51.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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German Center for Neurodegenerative Diseases (DZNE)