DementiaNCT05860127
Cognitive Stimulation Therapy for Dementia: A Two-Armed Pragmatic Trial
A study testing Referral for Cognitive Stimulation Therapy in people with Dementia and Cognitive Impairment, Mild, run by University of Massachusetts, Amherst at 2 sites in United States.
Trial summary
Cognitive Stimulation Therapy (CST) is an evidence-based non-pharmacological group therapy shown to benefit people with mild to moderate dementia. Despite increasing availability of CST worldwide, access remains limited in the United States. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dementia, Cognitive Impairment, Mild, Dementia, Vascular
- What is being tested?
- Referral for Cognitive Stimulation Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 133 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Apr 2023to 12 Jun 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Mild Cognitive Impairment or Mild to Moderate Dementia
- MoCA score of 10 to 26 OR SLUMS score of 10 to 26 OR MMSE score between 13 and 24 recorded as present < 24 months before the record review
- English-speaking
- Visit scheduled to include cognitive screening 6 to 12 months after record review.
Who cannot join
- Auditory or visual impairment, combative behaviors, or other clinician-assessed condition that would interfere with group treatment
- No access to online meeting platform
- Patient has specified to HCS not to engage patient in research or to use patient data in research
- Patient has previously participated in V-CST
- Physician determines a caregiver is needed to support V-CST participation, but no caregiver available to assist with technology.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UConn Center on Aging
Farmington, Connecticut, 06030
Yale Memory Clinic
New Haven, Connecticut, 06536
About this study
Cognitive Stimulation Therapy (CST) is an evidence-based non-pharmacological group therapy shown to benefit people with mild to moderate dementia. Despite increasing availability of CST worldwide, access remains limited in the United States. This pilot pragmatic trial will embed CST referral into the standard care protocol of health care settings that serve people living with dementia in the state of Connecticut, and evaluate online delivery of CST known as virtual CST (V-CST), and assess the acceptability of V-CST to people living with dementia.
The study design is a two-armed randomized embedded pragmatic clinical trial (ePCT). The trial aims to determine if cognitive decline is experienced less commonly among V-CST participants than control group members based on three widely used measures of cognition, the Montreal Cognitive Assessment (MoCA), St. Louis University Memory Screen (SLUMS), and Mini Mental State Exam (MMSE).
The study population will be persons with mild to moderate dementia identified by clinicians in standard care. From this population, subject participants will be randomized to intervention and control groups. Patients randomly assigned to the intervention group will be referred by their clinical providers to participate in V-CST, and those who accept the referral will participate in the intervention.
- Conditions
- Dementia, Cognitive Impairment, Mild, Dementia, Vascular, Dementia, Mixed, Dementia With Lewy Bodies, Dementia Frontal
- Being tested
- Referral for Cognitive Stimulation Therapy, No change to Standard of Care
- Medical subject headings
- Dementia, Cognitive Dysfunction, Dementia, Vascular, Mixed Dementias, Lewy Body Disease, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Referral for Cognitive Stimulation TherapyBehavioural
Physician will review participant eligibility for CST treatment and offer referral based on clinical judgement
No change to Standard of CareOther
Participants will not receive referral from a physician. They will continue with standard of care at their site.
| Study group | Role | What they receive |
|---|---|---|
| Referral for Cognitive Stimulation Therapy | Active comparator | This group will receive a referral from their physician for CST treatment Receives: Behavioral: Referral for Cognitive Stimulation Therapy |
| Standard of Care | Placebo comparator | This group will receive standard of care and no CST referral. Receives: Other: No change to Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive Impairment
Cognitive Impairment was assessed using one of the following cognitive assessment tools: Montreal Cognitive Assessment (MoCA), Saint Louis University Mental Status (SLUMS) exam, or the Mini-Mental State Examination (MMSE). A 'crosswalk' was used to convert all cognitive assessment measures to a MoCA score. MoCA scores range from 0-30, with 26+ generally considered normal, while scores below that suggest cognitive issues: 18-25 is often mild impairment, 10-17 is moderate, and under 10 is severe impairment. All participants started with a baseline MoCA score of 10 to 26 which indicates mild-moderate cognitive impairment.
Measured: 12 months
Secondary outcomes (3)
Percentage of Participants Who Accepted the Referral
V-CST referral will be favorably received by participants. V-CST referral will be assessed by referral acceptance rate measured by percentage of people referred for V-CST who accept the referral from their physician over the 1-month referral period process. This outcome will be assessed at the end of the referral process. The referral process is defined by the physician offering the referral to participants, the acceptance of the referral then leads to the physician sending the referral to the CBO to follow up.
Measured: 1 month
Percentage of Participants Who Completed Cognitive Stimulation Therapy
Participant completion will be measured as the percentage of enrolled participants who attend V-CST as a completer. A participant is considered a V-CST completer if they attend at least 8 or more of V-CST sessions. This outcome will be assessed at the end of the final V-CST session. Of the 50 participants randomized to the intervention, 42 participants were referred for V-CST.
Measured: 7 weeks
Percentage of Participants Who Did Not Complete CST
V-CST treatment will be favorably received by participants. Of the 50 participants randomized to the intervention, 42 participants were referred for V-CST, with 16 participants agreeing to participate and enrolled in V-CST. Participant attrition will be measured as the percentage of enrolled participants who cease attending V-CST between session 1 and session 14. V-CST sessions will be conducted over a 7-week period. This outcome will be assessed at the end of the 7th week V-CST session.
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study start10 Apr 2023
- Primary completion12 Jun 2025
- Study completion12 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DementiaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Amherst
- Sponsor type
- University, hospital or other
- Collaborators
- Yale University, UConn Health, National Institute on Aging (NIA), University of Maryland, Baltimore
- Responsible party
- Principal investigator, Michael Lepore, University of Massachusetts, Amherst
- Investigators
- Michael Lepore, PhD, Principal investigator, University of Massachusetts, Amherst
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05860127
- Sponsor's protocol ID
- Pro00054748
- Other IDs
- 5U54AG063546-04
- Status last verified
- Mar 2026
- First submitted
- 14 Feb 2023
- Last updated
- 23 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Stimulation Therapy for Dementia: A Two-Armed Pragmatic Trial
- ClinicalTrials.gov ID
- NCT05860127
- Acronym / sponsor ID
- Pro00054748
- Conditions
- Dementia, Cognitive Impairment, Mild, Dementia, Vascular, Dementia, Mixed, Dementia With Lewy Bodies, Dementia Frontal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- University of Massachusetts, AmherstUniversity, hospital or other
- Collaborators
- Yale University, UConn Health, National Institute on Aging (NIA), University of Maryland, Baltimore
- Study start
- 10 Apr 2023 (actual)
- Primary completion
- 12 Jun 2025 (actual)
- Study completion
- 12 Jun 2025 (actual)
- First posted
- 16 May 2023 (actual)
- Results
- Posted 23 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cognitive Stimulation Therapy (CST) is an evidence-based non-pharmacological group therapy shown to benefit people with mild to moderate dementia. Despite increasing availability of CST worldwide, access remains limited in the United States. This pilot pragmatic trial will embed CST referral into the standard care protocol of health care settings that serve people living with dementia in the state of Connecticut, and evaluate online delivery of CST known as virtual CST (V-CST), and assess the acceptability of V-CST to people living with dementia.
The study design is a two-armed randomized embedded pragmatic clinical trial (ePCT). The trial aims to determine if cognitive decline is experienced less commonly among V-CST participants than control group members based on three widely used measures of cognition, the Montreal Cognitive Assessment (MoCA), St. Louis University Memory Screen (SLUMS), and Mini Mental State Exam (MMSE).
The study population will be persons with mild to moderate dementia identified by clinicians in standard care. From this population, subject participants will be randomized to intervention and control groups. Patients randomly assigned to the intervention group will be referred by their clinical providers to participate in V-CST, and those who accept the referral will participate in the intervention.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Referral for Cognitive Stimulation Therapy | Active comparator | Behavioral: Referral for Cognitive Stimulation TherapyThis group will receive a referral from their physician for CST treatment |
| Standard of Care | Placebo comparator | Other: No change to Standard of CareThis group will receive standard of care and no CST referral. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of Mild Cognitive Impairment or Mild to Moderate Dementia
- MoCA score of 10 to 26 OR SLUMS score of 10 to 26 OR MMSE score between 13 and 24 recorded as present < 24 months before the record review
- English-speaking
- Visit scheduled to include cognitive screening 6 to 12 months after record review.
Key exclusion criteria (5 listed)
- Auditory or visual impairment, combative behaviors, or other clinician-assessed condition that would interfere with group treatment
- No access to online meeting platform
- Patient has specified to HCS not to engage patient in research or to use patient data in research
- Patient has previously participated in V-CST
- Physician determines a caregiver is needed to support V-CST participation, but no caregiver available to assist with technology.
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 |
|---|---|---|
| Referral for Cognitive Stimulation TherapyPhysician will review participant eligibility for CST treatment and offer referral based on clinical judgement | Behavioural | Referral for Cognitive Stimulation Therapy |
| No change to Standard of CareParticipants will not receive referral from a physician. They will continue with standard of care at their site. | Other | Standard of Care |
Primary outcome
Cognitive Impairment
Time frame: 12 months
Cognitive Impairment was assessed using one of the following cognitive assessment tools: Montreal Cognitive Assessment (MoCA), Saint Louis University Mental Status (SLUMS) exam, or the Mini-Mental State Examination (MMSE). A 'crosswalk' was used to convert all cognitive assessment measures to a MoCA score. MoCA scores range from 0-30, with 26+ generally considered normal, while scores below that suggest cognitive issues: 18-25 is often mild impairment, 10-17 is moderate, and under 10 is severe impairment. All participants started with a baseline MoCA score of 10 to 26 which indicates mild-moderate cognitive impairment.
3 secondary outcomes
Percentage of Participants Who Accepted the Referral
Time frame: 1 month
Percentage of Participants Who Completed Cognitive Stimulation Therapy
Time frame: 7 weeks
Percentage of Participants Who Did Not Complete CST
Time frame: 7 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Michael Lepore, PhD principal investigator
University of Massachusetts, Amherst
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Referral for Cognitive Stimulation Therapy in people with Dementia and Cognitive Impairment, Mild, run by University of Massachusetts, Amherst at 2 sites 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 23 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive Impairment (time frame: 12 months). 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 23 Mar 2026.