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Mild Cognitive ImpairmentNeurcog TAVRNCT05614986

Prospective Evaluation of Neurocognition in Patients Undergoing Transcatheter Aortic Valve Replacement

An observational study of Mild Cognitive Impairment and Aortic Stenosis, run by Baylor Research Institute at 4 sites 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

This trail is for patients with mild cognitive impairment (MCI) who are receiving a transcatheter aortic valve replacement (TAVR). We will assess changes in neurocognition following TAVR with the 5 minute Montreal Cognitive Assessment (mini MoCA) when comparing pre procedure with post procedure assessments. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Mild Cognitive Impairment, Aortic Stenosis
What is being tested?
5 minute Montreal Cognitive Assessment (mini MoCA)
How many people
81 participants
Where
4 sitesUnited States
Study dates
17 Jan 2022to 27 Feb 2024
Phase
Observational
Are there results?
None posted in the registry

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients undergoing TAVR with mild cognitive impairment

Who may be able to join

  • Age 18 years or older
  • Undergoing a TAVR procedure
  • Possible MCI as determined by procedures already used in the TAVR clinics, including 1 of the 4:
  • MMSE < 27
  • History of MCI, dementia, or stroke (CVA or TIA)
  • History of prescription treatment for MCI
  • Discretion of the investigator, physician, or clinic staff
  • Scores 25 or less on the mini MoCA exam

Who cannot join

  • 1. In another research study that doesn't allow dual enrolment, or dual enrolment has not been granted.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Baylor Heart and Vascular Hospital

    Dallas, Texas, 75226

  • Baylor Scott & White All Saints at Fort Worth

    Fort Worth, Texas, 76104

  • Baylor Scott and White The Heart Hospital Baylor Plano

    Plano, Texas, 75029

  • Baylor Scott & White Medical Center - Temple

    Temple, Texas, 76508

Other trials in United States

About this study

Official title: Prospective Evaluation of Neurocognition in Patients Undergoing Transcatheter Aortic Valve Replacement: Periprocedural Changes and Predictors of Improvement

This trail is for patients with mild cognitive impairment (MCI) who are receiving a transcatheter aortic valve replacement (TAVR). We will assess changes in neurocognition following TAVR with the 5 minute Montreal Cognitive Assessment (mini MoCA) when comparing pre procedure with post procedure assessments.

Read the detailed description

Patients with mild cognitive impairment who are being treated with a TAVR can choose to take part in this trial. This trial will prospectively enroll patients at 4 Baylor Scott \& White facilities. 80 patients will be enrolled between all sites. The mini MoCA will be conducted at the following time points: pre TAVR, 30 days post TAVR, and 6 months post TAVR. All other data will be collected from patient charts and are considered standard part of their care.

Being tested
5 minute Montreal Cognitive Assessment (mini MoCA)
Keywords
TAVR, Transcatheter Aortic Valve Replacement
Medical subject headings
Cognitive Dysfunction, Aortic Valve Stenosis

What participants receive

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

  • 5 minute Montreal Cognitive Assessment (mini MoCA)Other

    The mini MoCA will be completed by the patient before TAVR, and 30 days and 6 months after TAVR

Study groups in NCT05614986
Study groupRoleWhat they receive
Patients with Mild Cognitive Impairment Undergoing TAVRPatients will be treated with standard of care. In addition, patients will complete the mini MoCA at 3 time points
Receives: Other: 5 minute Montreal Cognitive Assessment (mini MoCA)

What is being measured

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

  1. Neurocognition measured by Mini MoCA at 30 days post TAVR

    Changes in neurocognition compared to baseline at 30 days

    Measured: 30 days post TAVR

Secondary outcomes (1)

  1. Neurocognition measured by Mini MoCA at 6 months post TAVR

    Changes in neurocognition compared to baseline at 6 months

    Measured: 6 months post TAVR

Timeline

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

  1. First posted14 Nov 2022
  2. Study start17 Jan 2022
  3. Primary completion2 Oct 2023
  4. Study completion27 Feb 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
81 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05614986
Sponsor's protocol ID
021-262
Acronym
Neurcog TAVR
Status last verified
Oct 2025
First submitted
7 Nov 2022
Last updated
27 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: IPD will not be shared with other researchers

Publications

  • Auffret V, Campelo-Parada F, Regueiro A, Del Trigo M, Chiche O, Chamandi C, Allende R, Cordoba-Soriano JG, Paradis JM, De Larochelliere R, Doyle D, Dumont E, Mohammadi S, Cote M, Marrero A, Puri R, Rodes-Cabau J. Serial Changes in Cognitive Function Following Transcatheter Aortic Valve Replacement. J Am Coll Cardiol. 2016 Nov 15;68(20):2129-2141. doi: 10.1016/j.jacc.2016.08.046. Epub 2016 Sep 28.

    PubMed 27692728

  • Potluri S, Szerlip M, Al-Azizi K, Harrington K, Kodali S, Kapadia S, Lu M, Leon MB, Mack MJ. Neurocognitive Function Change in Low-Risk Patients Undergoing TAVR Versus SAVR: Insights From PARTNER-3. JACC Cardiovasc Interv. 2020 Nov 23;13(22):2713-2714. doi: 10.1016/j.jcin.2020.08.009. No abstract available.

    PubMed 33213758

  • Arevalo-Rodriguez I, Smailagic N, Roque I Figuls M, Ciapponi A, Sanchez-Perez E, Giannakou A, Pedraza OL, Bonfill Cosp X, Cullum S. Mini-Mental State Examination (MMSE) for the detection of Alzheimer's disease and other dementias in people with mild cognitive impairment (MCI). Cochrane Database Syst Rev. 2015 Mar 5;2015(3):CD010783. doi: 10.1002/14651858.CD010783.pub2.

    PubMed 25740785

  • O'Bryant SE, Humphreys JD, Smith GE, Ivnik RJ, Graff-Radford NR, Petersen RC, Lucas JA. Detecting dementia with the mini-mental state examination in highly educated individuals. Arch Neurol. 2008 Jul;65(7):963-7. doi: 10.1001/archneur.65.7.963.

    PubMed 18625866

  • Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x.

    PubMed 15817019

  • Khan MM, Herrmann N, Gallagher D, Gandell D, Fremes SE, Wijeysundera HC, Radhakrishnan S, Sun YR, Lanctot KL. Cognitive Outcomes After Transcatheter Aortic Valve Implantation: A Metaanalysis. J Am Geriatr Soc. 2018 Feb;66(2):254-262. doi: 10.1111/jgs.15123. Epub 2017 Nov 21.

    PubMed 29159840

  • Liew TM. The Optimal Short Version of Montreal Cognitive Assessment in Diagnosing Mild Cognitive Impairment and Dementia. J Am Med Dir Assoc. 2019 Aug;20(8):1055.e1-1055.e8. doi: 10.1016/j.jamda.2019.02.004. Epub 2019 Mar 23.

    PubMed 30910550

  • Wong A, Nyenhuis D, Black SE, Law LS, Lo ES, Kwan PW, Au L, Chan AY, Wong LK, Nasreddine Z, Mok V. Montreal Cognitive Assessment 5-minute protocol is a brief, valid, reliable, and feasible cognitive screen for telephone administration. Stroke. 2015 Apr;46(4):1059-64. doi: 10.1161/STROKEAHA.114.007253. Epub 2015 Feb 19.

    PubMed 25700290

  • Roalf DR, Moore TM, Wolk DA, Arnold SE, Mechanic-Hamilton D, Rick J, Kabadi S, Ruparel K, Chen-Plotkin AS, Chahine LM, Dahodwala NA, Duda JE, Weintraub DA, Moberg PJ. Defining and validating a short form Montreal Cognitive Assessment (s-MoCA) for use in neurodegenerative disease. J Neurol Neurosurg Psychiatry. 2016 Dec;87(12):1303-1310. doi: 10.1136/jnnp-2015-312723. Epub 2016 Apr 12.

    PubMed 27071646

Questions about this trial

What is this clinical trial studying?

An observational study of Mild Cognitive Impairment and Aortic Stenosis, run by Baylor Research Institute at 4 sites 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 8 inclusion and 1 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 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Neurocognition measured by Mini MoCA at 30 days post TAVR (time frame: 30 days post TAVR). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05614986, which also lists 9 linked publications.

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 27 Jan 2026.

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