N/A
N=116
VIdeo Telehealth in ALzheimer's: NeuroPsychology (VITAL-NP)
Suspected Typical Alzheimer's Disease (AD) · Suspected Atypical Alzheimer's Disease (AD)
Bottom Line
View on ClinicalTrials.gov: NCT05379023 ↗Enrolled (actual)
116
Serious AEs
0.0%
Results posted
Dec 2025
Primary outcome: Primary: Agreement of Cognitive Test Results Across Testing Modalities as Measured by Neuropsychological Test Mean Scores, Measures With Total Correct Items — 4.31; 4.40; 8.21; 8.60 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Face-to-face evaluation (FF) (Behavioral); TeleNP evaluation (Behavioral)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- University of Colorado, Denver
- Primary completion
- May 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Agreement of Cognitive Test Results Across Testing Modalities as Measured by Neuropsychological Test Mean Scores, Measures With Total Correct Items |
4.31; 4.40; 8.21; 8.60; 12.40; 12.52 | — |
| PRIMARY Agreement of Neuropsychologist Diagnosis Across Testing Modalities as Measured by Neuropsychologist-Determined Diagnosis |
0.74 | — |
| PRIMARY Agreement of Neuropsychologist Appraisal of Severity Across Testing Modalities as Measured by Neuropsychologist-Determined Severity |
0.89 | — |
| PRIMARY Acceptability and Feasibility of Intervention Measures as Measured by 4-item Acceptability and Feasibility of Intervention Measures Scale |
4.0; 3.95; 4.0; 4.0; 4.0; 4.0 | — |
| PRIMARY Acceptability and Feasibility of Intervention Measures as Measured by 19-item UTAUT Questionnaire Adapted to TeleNP |
4.0; 4.0; 4.0 | — |
| PRIMARY Agreement of Cognitive Test Results Across Testing Modalities as Measured by Neuropsychological Test Mean Scores (Timed Measures) |
104.84; 96.29; 88.54; 79.59 | — |
Summary
The overarching goal of this study is to a) assess the feasibility and preliminary validity of home-based delivery of TeleNP to patients with suspected Alzheimer's Disease (AD), referred for cognitive assessments in a Neurology Clinic; and b) elucidate whether TeleNP is equivalent to face-to-face evaluation (FF) for diagnostic adjudication of atypical versus typical AD.
Eligibility Criteria
Inclusion Criteria
- Individuals age 60 to 90 years who are undergoing evaluation for possible AD and whose severity ranges from MCI to mild dementia.
- Individuals must carry a diagnosis of either suspected typical AD or atypical AD, based on the referring neurologist's diagnosis.
Exclusion Criteria
- Individuals with moderate to severe levels of dementia and individuals with active delirium (per neurologist's determination).
- Individuals who are legally blind or deaf, due to the auditory and visual components of the study.
- Individuals with a brain tumor and individuals who have a confirmed nonAD neurological diagnosis (e.g, Multiple Sclerosis; FTD).
- Individuals who are being evaluated outside of the UCH Memory Disorders Clinic.
- Individuals who report active (i.e., within the last 6 months) substance use of illicit drugs such as cocaine or methamphetamines, or who carry a diagnosis of a major psychiatric disorder (e.g., schizophrenia; bipolar disorder).
Note that care partners (3rd arm) did not undergo the intervention and there were no additional eligibility requirements for them except that they were involved in the patient's care
Data sourced from ClinicalTrials.gov (NCT05379023). 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.