DementiaNCT06638632
Decision Aid for Dementia Therapies
A study testing Decision aid in people with Dementia and Decision Aids, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The purpose of this study is to develop a decision aid to support patients and families making decisions about medications for dementia. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia, Decision Aids
- What is being tested?
- Decision aid
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2025to 28 Feb 2026
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients:
- UCHealth patient
- Ages 18 y/o and above
- Documented neurocognitive deficits suggestive of mild cognitive impairment or early dementia as determined by their treating clinician.
- English or Spanish speaking
- Caregiver:
Show all 12Show fewer
- Ages 18 y/o and above
- Identified by the study participant as the person who helps the most with their medical care outside the hospital or clinic.
- English or Spanish speaking
- Clinicians:
- Neurologists, primary care clinicians, pharmacists, or psychologists involved in dementia decision-making.
- English or Spanish speaking
Who cannot join
- Patients:
- Not English or Spanish-speaking
- Neurocognitive deficits suggestive of moderate or severe cognitive impairment or late stage dementia.
- Not able to consent for themselves
- Caregiver:
- Ages 17 y/o and below
Show all 10Show fewer
- Not English or Spanish-speaking
- Clinicians:
- Neurologists, primary care clinicians, pharmacists, or psychologists involved in dementia decision-making.
- English or Spanish-speaking
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Colorado
Aurora, Colorado, 80045
Kaitlynn Walton, MPH, 303-724-7162, kaitlynn.walton@cuanschutz.edu
Kate Noonan, kate.noonan@cuanschutz.edu
About this study
Official title: Helping Patients, Families, and Clinicians Make Shared Decisions About Therapies for Dementia
The purpose of this study is to develop a decision aid to support patients and families making decisions about medications for dementia.
- Conditions
- Dementia, Decision Aids
- Being tested
- Decision aid
- Keywords
- Lecanemab
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision aidBehavioural
Patients with dementia and care partners will receive an iteration of the decision aid and provide feedback.
| Study group | Role | What they receive |
|---|---|---|
| Decision Aid | Experimental | Participants provide feedback on the development of a decision aid for dementia therapies. Receives: Behavioral: Decision aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decisional Conflict
To access the preliminary efficacy on decisional conflict including personal perceptions of uncertainty in choosing options, factors that contribute to feelings of uncertainty and effective decision making.
Decisional Conflict Scale - Higher numbers mean more uncertainty. O'Connor, A. M. (1995). Validation of a decisional conflict scale. Medical decision making, 15(1), 25-30. https://decisionaid.ohri.ca/docs/develop/User_Manuals/UM_Decisional_Conflict.pdf
Measured: From enrollment at start of year 2 to the end of year 2
Shared Decision Making
To determine the extent that health care providers engage with patients as a part of their shared decision making, specifically looking at the discussion of treatment options and their pros and cons as well as the patient's preferences.
Shared Decision Making Process Scale - Higher numbers mean more shared decision making. https://mghdecisionsciences.org/tools-training/sdm-process-survey/
Measured: From enrollment at start of year 2 to the end of year 2
Decisional Self-Efficacy
To determine the patient's perception of their self-efficacy in decision making including measuring their self-confidence in their ability to make decisions.
Decision Self-Efficacy Scale where higher numbers mean they patient has a higher perception of self-efficacy.
https://decisionaid.ohri.ca/docs/develop/Tools/Decision_SelfEfficacy.pdf
Measured: From enrollment at start of year 2 to the end of year 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study startNov 2025 (estimated)
- Primary completionJan 2026 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is an iterative, user-centered design process. Therefore, patients and care partners will receive iterations of the decision aid as updates are made to it.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Dan Matlock, MD, MPH, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06638632
- Sponsor's protocol ID
- 24-0866
- Other IDs
- NIA Grant#: R21AG088955
- Status last verified
- Sep 2025
- First submitted
- 4 Oct 2024
- Last updated
- 16 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Elwyn G, Frosch D, Volandes AE, Edwards A, Montori VM. Investing in deliberation: a definition and classification of decision support interventions for people facing difficult health decisions. Med Decis Making. 2010 Nov-Dec;30(6):701-11. doi: 10.1177/0272989X10386231. Epub 2010 Nov 18.
PubMed 21088131van Dyck CH, Swanson CJ, Aisen P, Bateman RJ, Chen C, Gee M, Kanekiyo M, Li D, Reyderman L, Cohen S, Froelich L, Katayama S, Sabbagh M, Vellas B, Watson D, Dhadda S, Irizarry M, Kramer LD, Iwatsubo T. Lecanemab in Early Alzheimer's Disease. N Engl J Med. 2023 Jan 5;388(1):9-21. doi: 10.1056/NEJMoa2212948. Epub 2022 Nov 29.
PubMed 36449413
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Helping Patients, Families, and Clinicians Make Shared Decisions About Therapies for Dementia
- ClinicalTrials.gov ID
- NCT06638632
- Acronym / sponsor ID
- 24-0866
- Conditions
- Dementia, Decision Aids
- Keywords
- Lecanemab
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Nov 2025 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 15 Oct 2024 (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 purpose of this study is to develop a decision aid to support patients and families making decisions about medications for dementia.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is an iterative, user-centered design process. Therefore, patients and care partners will receive iterations of the decision aid as updates are made to it.
| Arm | Type | Receives |
|---|---|---|
| Decision Aid | Experimental | Behavioral: Decision aidParticipants provide feedback on the development of a decision aid for dementia therapies. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- UCHealth patient
- Ages 18 y/o and above
- Documented neurocognitive deficits suggestive of mild cognitive impairment or early dementia as determined by their treating clinician.
- English or Spanish speaking
- Ages 18 y/o and above
Key exclusion criteria (10 listed)
- Not English or Spanish-speaking
- Neurocognitive deficits suggestive of moderate or severe cognitive impairment or late stage dementia.
- Not able to consent for themselves
- Ages 17 y/o and below
- Not English or Spanish-speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Decision aidPatients with dementia and care partners will receive an iteration of the decision aid and provide feedback. | Behavioural | Decision Aid |
Primary outcome
Decisional Conflict
Time frame: From enrollment at start of year 2 to the end of year 2
To access the preliminary efficacy on decisional conflict including personal perceptions of uncertainty in choosing options, factors that contribute to feelings of uncertainty and effective decision making. Decisional Conflict Scale - Higher numbers mean more uncertainty. O'Connor, A. M. (1995). Validation of a decisional conflict scale. Medical decision making, 15(1), 25-30. https://decisionaid.ohri.ca/docs/develop/User_Manuals/UM_Decisional_Conflict.pdf
Shared Decision Making
Time frame: From enrollment at start of year 2 to the end of year 2
To determine the extent that health care providers engage with patients as a part of their shared decision making, specifically looking at the discussion of treatment options and their pros and cons as well as the patient's preferences. Shared Decision Making Process Scale - Higher numbers mean more shared decision making. https://mghdecisionsciences.org/tools-training/sdm-process-survey/
Decisional Self-Efficacy
Time frame: From enrollment at start of year 2 to the end of year 2
To determine the patient's perception of their self-efficacy in decision making including measuring their self-confidence in their ability to make decisions. Decision Self-Efficacy Scale where higher numbers mean they patient has a higher perception of self-efficacy. https://decisionaid.ohri.ca/docs/develop/Tools/Decision_SelfEfficacy.pdf
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 16 Sep 2025.
- Background: PubMed 21088131Elwyn G, Frosch D, Volandes AE, Edwards A, Montori VM. Investing in deliberation: a definition and classification of decision support interventions for people facing difficult health decisions. Med Decis Making. 2010 Nov-Dec;30(6):701-11. doi: 10.1177/0272989X10386231. Epub 2010 Nov 18.
- Background: PubMed 36449413van Dyck CH, Swanson CJ, Aisen P, Bateman RJ, Chen C, Gee M, Kanekiyo M, Li D, Reyderman L, Cohen S, Froelich L, Katayama S, Sabbagh M, Vellas B, Watson D, Dhadda S, Irizarry M, Kramer LD, Iwatsubo T. Lecanemab in Early Alzheimer's Disease. N Engl J Med. 2023 Jan 5;388(1):9-21. doi: 10.1056/NEJMoa2212948. Epub 2022 Nov 29.
- Individual participant dataSharing planned: No
Related trials for Dementia
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
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.
Dan Matlock, MD, MPH principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decision aid in people with Dementia and Decision Aids, run by University of Colorado, Denver at 1 site in United States.
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 12 inclusion and 10 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: opening soon, as of the sponsor's last update on 16 Sep 2025. 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 United States. 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 Kaitlynn Walton, MPH (303-724-7162, kaitlynn.walton@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decisional Conflict (time frame: From enrollment at start of year 2 to the end of year 2). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06638632, which also lists 2 linked publications.
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 16 Sep 2025.