Trial Outcomes & Findings for Cognitive Stimulation Therapy for Dementia: A Two-Armed Pragmatic Trial (NCT NCT05860127)

Last Updated: 2026-03-23

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

133 participants

Primary outcome timeframe

12 months

Results posted on

2026-03-23

Participant Flow

Subject participants were identified from patient panels of two physicians in two health care systems (HCSs), one at UConn Health and one at Yale. From review of EHR records at both sites, a total of 224 eligible patients were identified. Target enrollment was 168 participants. Physicians screened out 87 participants from the trial. After patient screening by physicians, a total of 133 participants were enrolled: 94 from the Yale site and 39 from UConn Health.

133 participants were randomly assigned to the intervention or control group. Participants were enrolled at the time of randomization.

Participant milestones

Participant milestones
Measure	Referral for Cognitive Stimulation Therapy This group will receive a referral from their physician for CST treatment	Standard of Care This group will receive standard of care and no CST referral.
Overall Study STARTED	50	83
Overall Study COMPLETED	47	80
Overall Study NOT COMPLETED	3	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Referral for Cognitive Stimulation Therapy This group will receive a referral from their physician for CST treatment	Standard of Care This group will receive standard of care and no CST referral.
Overall Study Death	3	3

Baseline Characteristics

1 unknown age for the control group

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Referral for Cognitive Stimulation Therapy n=50 Participants This group will receive a referral from their physician for CST treatment	Standard of Care n=83 Participants This group will receive standard of care and no CST referral.	Total n=133 Participants Total of all reporting groups
Sex: Female, Male Female	33 Participants n=50 Participants	47 Participants n=83 Participants	80 Participants n=133 Participants
Sex: Female, Male Male	17 Participants n=50 Participants	36 Participants n=83 Participants	53 Participants n=133 Participants
Race/Ethnicity, Customized White	44 Participants n=50 Participants	75 Participants n=83 Participants	119 Participants n=133 Participants
Race/Ethnicity, Customized Black or African American	4 Participants n=50 Participants	7 Participants n=83 Participants	11 Participants n=133 Participants
Race/Ethnicity, Customized Asian	1 Participants n=50 Participants	1 Participants n=83 Participants	2 Participants n=133 Participants
Race/Ethnicity, Customized Unknown	1 Participants n=50 Participants	0 Participants n=83 Participants	1 Participants n=133 Participants
Pre-assessment MoCA	19.60 scores on a scale STANDARD_DEVIATION 3.90 • n=50 Participants	19.76 scores on a scale STANDARD_DEVIATION 3.84 • n=83 Participants	19.70 scores on a scale STANDARD_DEVIATION 3.85 • n=133 Participants
Age, Continuous	72.5 years STANDARD_DEVIATION 12.46 • n=50 Participants • 1 unknown age for the control group	73.6 years STANDARD_DEVIATION 11.32 • n=82 Participants • 1 unknown age for the control group	73.2 years STANDARD_DEVIATION 11.32 • n=132 Participants • 1 unknown age for the control group

PRIMARY outcome

Timeframe: 12 months

Population: Participants were randomized to intervention or standard of care group.

Outcome measures

Outcome measures
Measure	Referral for Cognitive Stimulation Therapy n=50 Participants This group will receive a referral from their physician for CST treatment	Standard of Care n=83 Participants This group will receive standard of care and no CST referral.
Cognitive Impairment	19 Score on a scale Interval 5.64 to 34.64	19 Score on a scale Interval 6.51 to 31.49

SECONDARY outcome

Timeframe: 1 month

Population: Participants were evaluated based on acceptance of 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.

Outcome measures

Outcome measures
Measure	Referral for Cognitive Stimulation Therapy n=50 Participants This group will receive a referral from their physician for CST treatment	Standard of Care This group will receive standard of care and no CST referral.
Percentage of Participants Who Accepted the Referral Participant who accepted referral	42 Participants	—
Percentage of Participants Who Accepted the Referral Participants who declined referral offer	5 Participants	—
Percentage of Participants Who Accepted the Referral Participants not offered referral by physician	3 Participants	—

SECONDARY outcome

Timeframe: 7 weeks

Population: Participants evaluated based on participant attendance in CST

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.

Outcome measures

Outcome measures
Measure	Referral for Cognitive Stimulation Therapy n=42 Participants This group will receive a referral from their physician for CST treatment	Standard of Care This group will receive standard of care and no CST referral.
Percentage of Participants Who Completed Cognitive Stimulation Therapy Participants who accepted the referral and were approved by the CBO for V-CST participation	16 Participants	—
Percentage of Participants Who Completed Cognitive Stimulation Therapy Participants who completed V-CST (this row is a subset of first row)	9 Participants	—
Percentage of Participants Who Completed Cognitive Stimulation Therapy Participants who were lost to attrition before completing V-CST (this row is a subset of first row)	7 Participants	—

SECONDARY outcome

Timeframe: 7 weeks

Population: Of the 42 individuals referred for V-CST, 16 (38.1%) accepted the referral and were approved by the CBO for V-CST participation. Of these 16 individuals, nine (56.3%) completed V-CST and seven (43.7%) were lost to attrition before completing V-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.

Outcome measures

Outcome measures
Measure	Referral for Cognitive Stimulation Therapy n=16 Participants This group will receive a referral from their physician for CST treatment	Standard of Care This group will receive standard of care and no CST referral.
Percentage of Participants Who Did Not Complete CST Participants who completed V-CST	9 participants	—
Percentage of Participants Who Did Not Complete CST Participants who did not complete V-CST	7 participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

For each participant, we determined whether there was a decrease in psychotropic medications and no increase in psychotropic medications (i.e., favorable psychotropic medication outcomes), and then calculated the proportion of participants with favorable psychotropic medication outcomes across arms

Outcome measures

Outcome measures
Measure	Referral for Cognitive Stimulation Therapy n=50 Participants This group will receive a referral from their physician for CST treatment	Standard of Care n=83 Participants This group will receive standard of care and no CST referral.
Percentage of Participants With a Decrease and With no Increase in Psychotropic Medications	4 Participants	8 Participants

Adverse Events

Referral for Cognitive Stimulation Therapy

Serious events: 6 serious events

Other events: 3 other events

Deaths: 3 deaths

Standard of Care

Serious events: 9 serious events

Other events: 13 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	Referral for Cognitive Stimulation Therapy n=50 participants at risk This group will receive a referral from their physician for CST treatment	Standard of Care n=83 participants at risk This group will receive standard of care and no CST referral.
Infections and infestations Foot infection	0.00% 0/50 • Participants were reviewed for adverse events over a 12 month period Participants electronic health records were reviewed for doctors visits, emergency room visits, and hospitalizations.	1.2% 1/83 • Number of events 1 • Participants were reviewed for adverse events over a 12 month period Participants electronic health records were reviewed for doctors visits, emergency room visits, and hospitalizations.
Endocrine disorders Uncontrolled diabetes	0.00% 0/50 • Participants were reviewed for adverse events over a 12 month period Participants electronic health records were reviewed for doctors visits, emergency room visits, and hospitalizations.	1.2% 1/83 • Number of events 1 • Participants were reviewed for adverse events over a 12 month period Participants electronic health records were reviewed for doctors visits, emergency room visits, and hospitalizations.
General disorders Failure to thrive	2.0% 1/50 • Number of events 1 • Participants were reviewed for adverse events over a 12 month period Participants electronic health records were reviewed for doctors visits, emergency room visits, and hospitalizations.	1.2% 1/83 • Number of events 1 • Participants were reviewed for adverse events over a 12 month period Participants electronic health records were reviewed for doctors visits, emergency room visits, and hospitalizations.
Nervous system disorders Altered Mental Status	0.00% 0/50 • Participants were reviewed for adverse events over a 12 month period Participants electronic health records were reviewed for doctors visits, emergency room visits, and hospitalizations.	1.2% 1/83 • Number of events 1 • Participants were reviewed for adverse events over a 12 month period Participants electronic health records were reviewed for doctors visits, emergency room visits, and hospitalizations.
Metabolism and nutrition disorders Metabolic Encephalopathy	0.00% 0/50 • Participants were reviewed for adverse events over a 12 month period Participants electronic health records were reviewed for doctors visits, emergency room visits, and hospitalizations.	1.2% 1/83 • Number of events 1 • Participants were reviewed for adverse events over a 12 month period Participants electronic health records were reviewed for doctors visits, emergency room visits, and hospitalizations.
Cardiac disorders Cardiovascular Exacerbation	2.0% 1/50 • Number of events 1 • Participants were reviewed for adverse events over a 12 month period Participants electronic health records were reviewed for doctors visits, emergency room visits, and hospitalizations.	0.00% 0/83 • Participants were reviewed for adverse events over a 12 month period Participants electronic health records were reviewed for doctors visits, emergency room visits, and hospitalizations.
Renal and urinary disorders Perinephric hematoma	0.00% 0/50 • Participants were reviewed for adverse events over a 12 month period Participants electronic health records were reviewed for doctors visits, emergency room visits, and hospitalizations.	1.2% 1/83 • Number of events 1 • Participants were reviewed for adverse events over a 12 month period Participants electronic health records were reviewed for doctors visits, emergency room visits, and hospitalizations.
Infections and infestations Febrile Illness/Sepsis	2.0% 1/50 • Number of events 1 • Participants were reviewed for adverse events over a 12 month period Participants electronic health records were reviewed for doctors visits, emergency room visits, and hospitalizations.	0.00% 0/83 • Participants were reviewed for adverse events over a 12 month period Participants electronic health records were reviewed for doctors visits, emergency room visits, and hospitalizations.
Respiratory, thoracic and mediastinal disorders Respiratory illness	4.0% 2/50 • Number of events 2 • Participants were reviewed for adverse events over a 12 month period Participants electronic health records were reviewed for doctors visits, emergency room visits, and hospitalizations.	0.00% 0/83 • Participants were reviewed for adverse events over a 12 month period Participants electronic health records were reviewed for doctors visits, emergency room visits, and hospitalizations.
Nervous system disorders Parkinson's disease	0.00% 0/50 • Participants were reviewed for adverse events over a 12 month period Participants electronic health records were reviewed for doctors visits, emergency room visits, and hospitalizations.	1.2% 1/83 • Number of events 1 • Participants were reviewed for adverse events over a 12 month period Participants electronic health records were reviewed for doctors visits, emergency room visits, and hospitalizations.
Respiratory, thoracic and mediastinal disorders COPD exacerbation	0.00% 0/50 • Participants were reviewed for adverse events over a 12 month period Participants electronic health records were reviewed for doctors visits, emergency room visits, and hospitalizations.	1.2% 1/83 • Number of events 1 • Participants were reviewed for adverse events over a 12 month period Participants electronic health records were reviewed for doctors visits, emergency room visits, and hospitalizations.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	2.0% 1/50 • Number of events 1 • Participants were reviewed for adverse events over a 12 month period Participants electronic health records were reviewed for doctors visits, emergency room visits, and hospitalizations.	0.00% 0/83 • Participants were reviewed for adverse events over a 12 month period Participants electronic health records were reviewed for doctors visits, emergency room visits, and hospitalizations.
Cardiac disorders Trcyclic acid overdose	0.00% 0/50 • Participants were reviewed for adverse events over a 12 month period Participants electronic health records were reviewed for doctors visits, emergency room visits, and hospitalizations.	1.2% 1/83 • Number of events 1 • Participants were reviewed for adverse events over a 12 month period Participants electronic health records were reviewed for doctors visits, emergency room visits, and hospitalizations.

Other adverse events

Other adverse events
Measure	Referral for Cognitive Stimulation Therapy n=50 participants at risk This group will receive a referral from their physician for CST treatment	Standard of Care n=83 participants at risk This group will receive standard of care and no CST referral.
General disorders Fall	2.0% 1/50 • Number of events 1 • Participants were reviewed for adverse events over a 12 month period Participants electronic health records were reviewed for doctors visits, emergency room visits, and hospitalizations.	10.8% 9/83 • Number of events 9 • Participants were reviewed for adverse events over a 12 month period Participants electronic health records were reviewed for doctors visits, emergency room visits, and hospitalizations.
General disorders Pain	4.0% 2/50 • Number of events 2 • Participants were reviewed for adverse events over a 12 month period Participants electronic health records were reviewed for doctors visits, emergency room visits, and hospitalizations.	4.8% 4/83 • Number of events 4 • Participants were reviewed for adverse events over a 12 month period Participants electronic health records were reviewed for doctors visits, emergency room visits, and hospitalizations.

Additional Information

Dr. Michael Lepore

University of Massachusetts Amherst

Phone: 4135455093

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place