NCT03868345

Brief Summary

The purpose of this study is to find out if changes in speech can signal changes in the ability to think or remember. ALS patients with and without cognitive dysfunction will be followed for one year. Every three months, patients will undergo a series of cognitive and basic clinical outcomes tests. In addition, participants will take home a study-provided tablet on which they will complete weekly speech recording activities.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2019

Completed
12 days until next milestone

Study Start

First participant enrolled

February 18, 2019

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 11, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
Last Updated

March 9, 2023

Status Verified

March 1, 2023

Enrollment Period

2.2 years

First QC Date

February 6, 2019

Last Update Submit

March 7, 2023

Conditions

ALSAmyotrophic Lateral SclerosisLou Gehrig Disease

Keywords

ALSCognitive dysfunctionSpeech

Outcome Measures

Primary Outcomes (1)

  • Change in ability on Speech and Language Battery

    Speech recordings made at home via a tablet using the " SpeechAssess" app.

    Weekly recordings for one year

Secondary Outcomes (5)

  • Change in Montreal Cognitive Assessment

    Administered every three months for a year

  • Change in ALS Cognitive Behavioral Screen

    Administered every three months for a year

  • Change in Vital Capacity

    Administered every three months for a year

  • Change in Negative Inspiratory Force

    Administered every three months for a year

  • Change in "ALS Functional Rating Scale- Revised"

    Administered every three months for a year

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with ALS, diagnosed as definite, probable, or possible ALS according to the modified El Escorial Criteria.

You may qualify if:

  • male or female, age 21 or older,
  • diagnosed with definite, probable, or possible ALS according to the modified El Escorial Criteria,
  • a score of 2 or greater on the speech question of the ALSFRS-R (i.e. speech is intelligible with occasional repetition),
  • continuous internet access at home,
  • willingness and medical ability to comply with scheduled visits and study procedures,
  • ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations,
  • geographic accessibility to study site,
  • for the 25 participants in Group 1, NO noted symptoms of frontotemporal cognitive dysfunction, and
  • for the 25 participants in Group 2, MUST have cognitive symptoms as noted either by themselves or a caregiver.

You may not qualify if:

  • unwilling or unable to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the participant's ability to comply with the protocol, and
  • any other reasons that, in the opinion of the PI, cause the candidate to be deemed unsuitable for entry into the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Barrow Neurological Institute

Phoenix, Arizona, 85013, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood serum and blood plasma to be collected at three timepoints and retained in a biorepository.

MeSH Terms

Conditions

Amyotrophic Lateral SclerosisCognitive DysfunctionSpeech

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesMotor Neuron DiseaseNeurodegenerative DiseasesTDP-43 ProteinopathiesNeuromuscular DiseasesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic DiseasesCognition DisordersNeurocognitive DisordersMental DisordersVerbal BehaviorCommunicationBehavior

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Vice President and Chair of Neurology

Study Record Dates

First Submitted

February 6, 2019

First Posted

March 11, 2019

Study Start

February 18, 2019

Primary Completion

April 30, 2021

Study Completion

April 30, 2021

Last Updated

March 9, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)