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Suspected Typical Alzheimer's Disease (AD)VITAL-NPNCT05379023

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

A study testing Face-to-face evaluation (FF) and TeleNP evaluation in people with Suspected Typical Alzheimer's Disease (AD) and Suspected Atypical Alzheimer's Disease (AD), run by University of Colorado, Denver at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 60 to 90 years
What is being tested?
Face-to-face evaluation (FF) and TeleNP evaluation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
116 participants
Where
1 siteUnited States
Study dates
27 Jun 2022to 16 May 2024
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 60 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Colorado Anschutz Medical Campus (CU-AMC)

    Aurora, Colorado, 80045

Other trials in United States

About this study

Official title: Integrating Home-Based Video Teleneuropsychology Into Clinical Practice: Typical Versus Atypical Alzheimer's Disease

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.

Being tested
Face-to-face evaluation (FF), TeleNP evaluation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Face-to-face evaluation (FF)Behavioural

    The intervention is the assessment modality. The control condition is face-to-face evaluation (FF).

  • TeleNP evaluationBehavioural

    The intervention is the assessment modality. The intervention condition is TeleNP evaluation.

Study groups in NCT05379023
Study groupRoleWhat they receive
Face-to-face evaluation (FF), TeleNP evaluationOtherIn-Person (standard of care) Modality completed first, Telehealth Modality completed second
Receives: Behavioral: Face-to-face evaluation (FF); Behavioral: TeleNP evaluation
TeleNP evaluation, Face-to-face evaluation (FF)OtherTelehealth Modality completed first, In-Person (standard of care) Modality completed second
Receives: Behavioral: Face-to-face evaluation (FF); Behavioral: TeleNP evaluation
Care PartnersNo interventionCare Partners did not undergo the intervention; they completed outcome measures (surveys) of acceptability only.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Agreement of Cognitive Test Results Across Testing Modalities as Measured by Neuropsychological Test Mean Scores, Measures With Total Correct Items

    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) - total correct) (range: 0- no limit). Higher=better.

    JoLO=Judgment of Line Orientation (Spatial) -total correct (range: 0-15). Higher=better

    Measured: After the exposure to each health delivery conditions, Face-to-face evaluation (FF) and TeleNP evaluation, at Week 1 and Weeks 5-7

  2. Agreement of Neuropsychologist Diagnosis Across Testing Modalities as Measured by Neuropsychologist-Determined Diagnosis

    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.

    Measured: After the exposure to each health delivery conditions, Face-to-face evaluation (FF) and TeleNP evaluation, at Week 1 and Weeks 5-7

  3. Agreement of Neuropsychologist Appraisal of Severity Across Testing Modalities as Measured by Neuropsychologist-Determined Severity

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

    Measured: After the exposure to each health delivery conditions, Face-to-face evaluation (FF) and TeleNP evaluation, at Week 1 and Weeks 5-7

  4. Acceptability and Feasibility of Intervention Measures as Measured by 4-item Acceptability and Feasibility of Intervention Measures Scale

    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).

    Measured: After the exposure to each health delivery conditions, Face-to-face evaluation (FF) and TeleNP evaluation, at Week 1 and Weeks 5-7

  5. Acceptability and Feasibility of Intervention Measures as Measured by 19-item UTAUT Questionnaire Adapted to TeleNP

    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 technology.

    Measured: After the exposure to the TeleNP evaluation (up to Week 7)

  6. Agreement of Cognitive Test Results Across Testing Modalities as Measured by Neuropsychological Test Mean Scores (Timed Measures)

    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

    Measured: After the exposure to each health delivery conditions, Face-to-face evaluation (FF) and TeleNP evaluation, at Week 1 and Weeks 5-7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2022
  2. Study start27 Jun 2022
  3. Primary completion16 May 2024
  4. Study completion16 May 2024

Resources

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
Diagnosis
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Investigator
Enrolment
116 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05379023
Sponsor's protocol ID
21-5037
Other IDs
R21AG072153
Acronym
VITAL-NP
Status last verified
Dec 2025
First submitted
2 May 2022
Last updated
31 Dec 2025
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Face-to-face evaluation (FF) and TeleNP evaluation in people with Suspected Typical Alzheimer's Disease (AD) and Suspected Atypical Alzheimer's Disease (AD), run by University of Colorado, Denver at 1 site 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 2 inclusion and 6 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 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. 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 31 Dec 2025). 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?

Agreement of Cognitive Test Results Across Testing Modalities as Measured by Neuropsychological Test Mean Scores, Measures With Total Correct Items (time frame: After the exposure to each health delivery conditions, Face-to-face evaluation (FF) and TeleNP evaluation, at Week 1 and Weeks 5-7). The study lists 6 primary outcomes in all. 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 31 Dec 2025.

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