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Parkinson DiseaseSLAM-PDNCT04273672

Speech, Linguistic and Acoustic Markers in Parkinson's Disease

An observational study of Parkinson Disease and Cognitive Impairment, Mild, run by University of Massachusetts, Worcester 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 Investigators aim to identify speech and language markers that provide information on cognitive function and predict cognitive decline in Parkinson's disease. The Investigators will administer speech tasks and cognitive assessments to participants with Parkinson's disease and healthy controls. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Cognitive Battery, Voice, Speech and Language Analysis and Questionnaires and Clinical Assessments
How many people
58 participants
Where
1 siteUnited States
Study dates
13 Jan 2020to 28 Feb 2025
Phase
Observational
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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Adults with Parkinson's Disease and mild cognitive impairment or normal cognition as well as controls

Who may be able to join

  • Parkinson's Disease (or healthy control)
  • Disease duration ≥ 2 years
  • Mild cognitive impairment or normal cognition

Who cannot join

  • Diagnosis of dementia (MoCA <21)
  • Adults unable to consent
  • Age < 18
  • Pregnant women
  • Prisoners
  • Non-English speakers
Show all 12Show fewer
  • Any neurological disorder other than PD
  • Deep brain stimulator placement
  • Severe, unstable psychiatric disorder
  • Unintelligible speech due to effects of PD
  • Visual acuity or color vision impairment that would interfere with cognitive testing
  • Other voice, speech or swallowing disorders or history of surgery involving palate/nasopharynx/larynx/vocal cords

Trial locations and contacts

1 site in 1 country.

United States1 site
  • UMass Medical School/UMass Memorial Medical Center

    Worcester, Massachusetts, 01655

Other trials in United States

About this study

The Investigators aim to identify speech and language markers that provide information on cognitive function and predict cognitive decline in Parkinson's disease. The Investigators will administer speech tasks and cognitive assessments to participants with Parkinson's disease and healthy controls. The Investigators will also explore the associations between genetic factors and speech and cognitive status in Parkinson's disease.

Being tested
Cognitive Battery, Voice, Speech and Language Analysis, Questionnaires and Clinical Assessments, DNA Analysis
Medical subject headings
Parkinson Disease, Cognitive Dysfunction, Speech

What participants receive

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

  • Cognitive BatteryDiagnostic test

    Participants will be asked to complete a series of cognitive testing (testing of concentration, memory, and other thinking abilities).

  • Voice, Speech and Language AnalysisBehavioural

    Participants will be asked to perform speaking and reading tasks, which will be recorded. Participants will be asked to complete a laptop-based test of language comprehension.

  • Questionnaires and Clinical AssessmentsBehavioural

    Participants with Parkinson's disease will complete an examination of their symptoms and questionnaires assessing disease symptoms, mood and activities of daily living. Healthy controls participants will be asked to complete questionnaires on mood.

  • DNA AnalysisGenetic

    Participants will have their blood drawn for DNA analysis.

Study groups in NCT04273672
Study groupRoleWhat they receive
Parkinson's DiseaseSubjects with Parkinson's Disease
Receives: Diagnostic Test: Cognitive Battery; Behavioral: Voice, Speech and Language Analysis; Behavioral: Questionnaires and Clinical Assessments; Genetic: DNA Analysis
ControlSubjects without Parkinson's Disease
Receives: Diagnostic Test: Cognitive Battery; Behavioral: Voice, Speech and Language Analysis; Behavioral: Questionnaires and Clinical Assessments

What is being measured

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

  1. Mild Cognitive Impairment

    Mild cognitive impairment classified by Movement Disorders Society Task Force Level II Critieria

    Measured: baseline

  2. Mean Fundamental Frequency

    These acoustic measures during spontaneous speech (picture description) were calculated using Praat

    Measured: baseline

Timeline

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

  1. First posted18 Feb 2020
  2. Study start13 Jan 2020
  3. Primary completion1 Sep 2023
  4. Study completion28 Feb 2025

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
Cross-sectional
Enrolment
58 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04273672
Sponsor's protocol ID
H00011523
Other IDs
5K23DC016656
Acronym
SLAM-PD
Status last verified
Jun 2025
First submitted
12 Feb 2020
Last updated
10 Jun 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Parkinson Disease and Cognitive Impairment, Mild, run by University of Massachusetts, Worcester 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 3 inclusion and 12 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 10 Jun 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 10 Jun 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?

Mild Cognitive Impairment (time frame: baseline). The study lists 2 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 10 Jun 2025.

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