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NCT05379023: VITAL-NP

VIdeo Telehealth in ALzheimer's: NeuroPsychology (VITAL-NP)

Completed NA Results posted Last updated 31 December 2025
What this trial tests

NA trial testing Face-to-face evaluation (FF) in Suspected Typical Alzheimer's Disease (AD) in 116 participants. Completed in 16 May 2024.

Timeline
27 June 2022
Primary endpoint
16 May 2024
16 May 2024

Quick facts

Lead sponsorUniversity of Colorado, Denver
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingsingle
Primary purposediagnostic
Enrollment116
Start date27 June 2022
Primary completion16 May 2024
Estimated completion16 May 2024
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Colorado, Denver

Who can join

Adults 60 to 90, any sex, with Suspected Typical Alzheimer's Disease (AD) or Suspected Atypical Alzheimer's Disease (AD). Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Agreement of Cognitive Test Results Across Testing Modalities as Measured by Neuropsychological Test Mean Scores, Measures With Total Correct Items Primary · After the exposure to each health delivery conditions, Face-to-face evaluation (FF) and TeleNP evaluation, at Week 1 and Weeks 5-7

Raw scores for measures of Memory, Executive Functions, Language, and Spatial Abilities will be compared across both conditions. CVLT= California Verbal Learning Test- 2nd edition; Delayed recall measures Memory, total words recalled after 20-minutes (range: 0-16). Higher=better. RBANS = Repeatable Battery for the Assessment of Neuropsychological Status; Delayed recall (Memory) - total elements recalled (range: 0-20). Higher=better. Figure Copy (Spatial)- total copied (range: 0-20). BNT=Boston Naming Test (Language) -total correct (range: 0-15). Higher=better. Category Fluency (Language) -

CVLT Delayed Recall (Memory). Total Score, Higher=better score.
GroupValue95% CI
Teleneuropsychology (TeleNP)4.31± 4.30
Face-to-Face (FF)4.40± 4.20
RBANS Figure Delayed Recall (Memory). Total Score, Higher=better score.
GroupValue95% CI
Teleneuropsychology (TeleNP)8.21± 5.20
Face-to-Face (FF)8.60± 4.90
BNT-15 item Total (Language), Total Score, Higher=better score.
GroupValue95% CI
Teleneuropsychology (TeleNP)12.40± 3.20
Face-to-Face (FF)12.52± 3.20
Category Fluency Total (Language), Total Score, Higher=better score.
GroupValue95% CI
Teleneuropsychology (TeleNP)13.19± 5.50
Face-to-Face (FF)12.83± 5.80
JoLO 15-item Total (Spatial), Total Score, Higher=better score.
GroupValue95% CI
Teleneuropsychology (TeleNP)10.60± 3.40
Face-to-Face (FF)11.10± 3.00
RBANS Figure Copy (Spatial), Total Score, Higher=better score.
GroupValue95% CI
Teleneuropsychology (TeleNP)17.08± 2.50
Face-to-Face (FF)17.21± 2.60
Agreement of Neuropsychologist Diagnosis Across Testing Modalities as Measured by Neuropsychologist-Determined Diagnosis Primary · After the exposure to each health delivery conditions, Face-to-face evaluation (FF) and TeleNP evaluation, at Week 1 and Weeks 5-7

Neuropsychologist-determined diagnosis (i.e., typical AD, atypical/complex AD, not AD) will be compared across both conditions whether TeleNP alters assessment of patient diagnosis.

GroupValue95% CI
Syndrome Across Modalities0.740.60 – 0.88
Agreement of Neuropsychologist Appraisal of Severity Across Testing Modalities as Measured by Neuropsychologist-Determined Severity Primary · After the exposure to each health delivery conditions, Face-to-face evaluation (FF) and TeleNP evaluation, at Week 1 and Weeks 5-7

Neuropsychologist-determined severity (i.e., subjective cognitive concerns; MCI; mild dementia) will be compared across both conditions whether TeleNP alters assessment of patient severity.

GroupValue95% CI
Severity Across Modalities0.890.79 – 0.99
Acceptability and Feasibility of Intervention Measures as Measured by 4-item Acceptability and Feasibility of Intervention Measures Scale Primary · After the exposure to each health delivery conditions, Face-to-face evaluation (FF) and TeleNP evaluation, at Week 1 and Weeks 5-7

The 4-item Acceptability and Feasibility of Intervention Measures Scale is used for rating all participants and care partners' perspective on the acceptability and feasibility of the Face-to-face evaluation (FF) and TeleNP evaluation as assessed using a 5-point Likert scale at Week 1 or Weeks 5-7, depending on randomization. Scores range from "Completely disagree" (1) to "Completely agree" (5).

TeleNP. Acceptability of Intervention Measure. Range 1-5; Higher=More Acceptable
GroupValue95% CI
Patient (Acceptability Measure)4.03.5 – 4.5
Care Partner (Acceptability Measure)3.953.3 – 4.8
TeleNP. Intervention Appropriateness Measure. Range 1-5; Higher=More Acceptable
GroupValue95% CI
Patient (Acceptability Measure)4.03.5 – 4.3
Care Partner (Acceptability Measure)4.03.5 – 4.5
TeleNP. Feasibility of Intervention Measure. Range 1-5; Higher=More Acceptable
GroupValue95% CI
Patient (Acceptability Measure)4.03.8 – 4.5
Care Partner (Acceptability Measure)4.03.8 – 4.8
FF (Face-to-Face). Acceptability of Intervention Measure. Range 1-5; Higher=More Acceptable
GroupValue95% CI
Patient (Acceptability Measure)4.03.5 – 5.0
Care Partner (Acceptability Measure)3.93.5 – 4.3
FF (Face-to-Face). Intervention Appropriateness Measure. Range 1-5; Higher=More Acceptable
GroupValue95% CI
Patient (Acceptability Measure)4.04.0 – 4.8
Care Partner (Acceptability Measure)4.04.0 – 4.8
FF (Face-to-Face). Feasibility of Intervention Measure. Range 1-5; Higher=More Acceptable
GroupValue95% CI
Patient (Acceptability Measure)4.03.8 – 4.8
Care Partner (Acceptability Measure)4.03.8 – 4.8
Acceptability and Feasibility of Intervention Measures as Measured by 19-item UTAUT Questionnaire Adapted to TeleNP Primary · After the exposure to the TeleNP evaluation (up to Week 7)

The UTAUT questionnaire adapted to TeleNP is used for rating all participants' perspective on the acceptability and feasibility of TeleNP evaluation as assessed using a 5-point Likert scale at Week 1 or Weeks 5-7, depending on randomization. Scores range from "Strongly disagree" (1) to "Strongly agree" (5). Performance expectancy refers to the degree to which an individual believes that using a technology will help them improve their performance. Effort expectancy is the degree of ease associated with using the technology. Behavioral intention reflects an individual's plan to use the technol

Performance Expectancy Domain
GroupValue95% CI
Patient (UTAUT Measure)4.03.0 – 5.0
Effort Expectancy Domain
GroupValue95% CI
Patient (UTAUT Measure)4.03.0 – 4.0
Behavioral Intention Domain
GroupValue95% CI
Patient (UTAUT Measure)4.03.0 – 4.0
Agreement of Cognitive Test Results Across Testing Modalities as Measured by Neuropsychological Test Mean Scores (Timed Measures) Primary · After the exposure to each health delivery conditions, Face-to-face evaluation (FF) and TeleNP evaluation, at Week 1 and Weeks 5-7

Raw scores for measures of Executive Functions will be compared across both conditions. DKEFS= Delis-Kaplan Executive Function Systems; Color-Word Inhibition (Executive Functions) -total time (range: 0-180"). Higher=worse Oral Trail Making Test B (Executive Functions) total time (range: 0-300"). Higher=worse

DKEFS Color-Word Inhibition Total Time
GroupValue95% CI
Teleneuropsychology (TeleNP)104.84± 44.10
Face-to-Face (FF)96.29± 38.10
Oral Trail Making Test, Total Time
GroupValue95% CI
Teleneuropsychology (TeleNP)88.54± 87.10
Face-to-Face (FF)79.59± 83.30

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing