N/A N=61 Randomized Single-blind Supportive Care

User-Led Meaningful Activity and Early-Stage Dementia

Dementia

Bottom Line

View on ClinicalTrials.gov: NCT05159869 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2026

Primary outcome: Primary: Change in Global Cognitive Function as Assessed by the Wechsler Memory Scale-III — -0.2; -0.2 score on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: User-Led Meaningful Activity Plan (Behavioral)
Age: Adult, Older Adult · 60+ yrs
Sex: All
Sponsor: Johns Hopkins University
Primary completion: Jun 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Global Cognitive Function as Assessed by the Wechsler Memory Scale-III	-0.2; -0.2	—
PRIMARY Change in the Cognitive Domain of Attention as Assessed by the Wechsler Adult Intelligence Scale-IV Digit Span Test	0.6; -0.2	—
PRIMARY Change in the Cognitive Domain of Processing Speed as Assessed by the Trail-Making Test Part A	2.6; -0.2	—
PRIMARY Change in the Cognitive Domain of Executive Function as Assessed by the Trail-Making Test Part B	2.7; -0.6	—
PRIMARY Change in the Cognitive Domain of Executive Function as Assessed by the Stroop Color-Word Test	1.1; 0.4	—
PRIMARY Change in the Cognitive Domain of Executive Function as Assessed by the Clock Drawing Test (CLOX1)	1.3; 0.2	—
PRIMARY Change in the Cognitive Domain of Immediate Memory and Learning as Assessed by the Repeatable Battery for the Assessment of Neuropsychological Status List Learning Subtest	2.7; 0.1	—
PRIMARY Change in the Cognitive Domains of Memory and Learning as Assessed by the Repeatable Battery for the Assessment of Neuropsychological Status Story Memory Subtest	1.8; 0.3	—
PRIMARY Change in the Cognitive Domain of Delayed Memory as Assessed by the Repeatable Battery for the Assessment of Neuropsychological Status List Recall Subtest	1.2; 0.2	—
PRIMARY Change in the Cognitive Domain of Delayed Memory as Assessed by the Repeatable Battery for the Assessment of Neuropsychological Status List Recognition Subtest	1.1; 0.2	—
PRIMARY Change in the Cognitive Domain of Delayed Memory as Assessed by the Repeatable Battery for the Assessment of Neuropsychological Status Story Memory Subtest	1.4; 0.3	—
PRIMARY Change in the Cognitive Domain of Immediate Visual Memory as Assessed by the Rey-Osterrieth Complex Figure Test	1.7; 0.4	—
PRIMARY Change in the Cognitive Domain of Delayed Visual Memory as Assessed by the Rey-Osterrieth Complex Figure Test	0.9; 0.2	—
PRIMARY Change in the Cognitive Domain of Language as Assessed by the Controlled Oral Word Association Test	2.5; 0.4	—
PRIMARY Change in the Cognitive Domain of Language as Assessed by the Boston Naming Test	2.1; 0.6	—
PRIMARY Change in the Cognitive Domain of Language as Assessed by the Repeatable Battery for the Assessment of Neuropsychological Status Semantic Fluency	1.5; 0.5	—
PRIMARY Change in the Cognitive Domain of Visuospatial Constructional Ability as Assessed by the Rey-Osterrieth Complex Figure Test	1.1; 0.2	—
PRIMARY Change in the Frequency x Severity of Neuropsychiatric Symptoms in Persons With Dementia as Assessed by the Neuropsychiatric Inventory (NPI)	-4.4; -1.0	—
PRIMARY Change in the Cognitive Domain of Visuospatial Ability as Assessed by the Repeatable Battery for the Assessment of Neuropsychological Status Line Orientation	0.4; 0.2	—
SECONDARY Change in Depression as Assessed by the Geriatric Depression Scale	-1.3; -0.2	—
SECONDARY Change in Anxiety as Assessed by the Geriatric Anxiety Inventory	-2.4; -0.6	—
SECONDARY Change in Sense of Control as Assessed by the MIDI Sense of Control Scale	3.6; 0.7	—
SECONDARY Change in Sense of Control as Assessed by the Wallhagen Perceived Control Questionnaire	3.1; 0.8	—
SECONDARY Change in Sense of Self as Assessed by the Identity-Alzheimer Moderate Test	0.08; 0.01	—
SECONDARY Change in Sense of Self as Assessed by the IMAGE Test	3.5; 0.7	—

Summary

Neuropsychiatric symptoms are the most difficult, distressing, and burdensome aspects of dementia care and a catalyst for long-term care placement. Intervention studies have largely focused on helping caregivers manage these symptoms. However, little has been done with regard to persons at the earliest stages of dementia, nor have persons with dementia played a direct and active, central role in helping to design intervention studies. This study focuses on building, pilot testing, and evaluating a tailored activity plan developed with persons with early-stage dementia. The goal of the intervention is to provide persons at this early stage meaningful activities and a plan for adaptation with disease progression.

Eligibility Criteria

Inclusion Criteria

Persons with dementia must:

Be English-speaking
Have a diagnosis of early-stage dementia based on standard assessments and diagnostic criteria [e.g., Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5)]
Be medically stable and responsive to the environment (e.g., not comatose). If participants with dementia are on any of four classes of psychotropic medications (antidepressant, benzodiazepines, antipsychotic, or anti-convulsant) or an anti-dementia medication (memantine or a cholinesterase inhibitor), the investigators will require that participants have been on a stable dose for 60 days prior to enrollment (typical time frame in clinical trials) to minimize possible confounding effects of concomitant medications.

Exclusion Criteria

Dementia in the moderate or severe stages
Bed-boundedness, defined as confined to bed or chair for at least 22 hours a day for at least four of the previous seven days
Are receiving palliative care or are at end-of-life
A diagnosis of schizophrenia or a bipolar disorder
Dementia secondary to probable head trauma
The participant is taking any neuroleptic medications or has any of the following medical diagnosis: (a) restless legs syndrome, (b) delirium, or (c) akathisia, medication-induced, or other movement disorders such as Parkinson's disease or essential tremor.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05159869). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.