An Observational Study of Patients Living With Chronic Neurological Diseases

NCT05796037 | Not Yet Recruiting

• 1 other identifier: TARGET-NEURO
• Study Type: observational
• Target: 1,500,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

TARGET-NEURO is an observational research study to conduct a comprehensive review of outcomes for patients living with chronic neurological diseases: Alzheimer's disease and related dementia (ADRD), mild cognitive impairment (MCI), Parkinson's disease (PD), and multiple sclerosis (MS).

Conditions

Neurological Diseases or Conditions; Dementia of Alzheimer Type; Alzheimer Disease; Mild Cognitive Impairment; Parkinson Disease; Multiple Sclerosis

Outcome Measures

Primary Outcomes (2)

• To characterize the natural history of disease in patients living with chronic neurological diseases including ADRD, MCI, PD, or MS

  A detailed analysis of available demographics (age, race, sex, country of birth, insurance status), medications, co-morbidities, and medical history from sites across the US will inform the profile for this patient population. Data from retrospective and prospectively collected medical records will be curated and analyzed to characterize disease natural history and current treatment paradigms. These data may also establish incidence rates of events of special interest. Collection of prospective medical records for each patient enables the continuation of these analyses longitudinally for changes and progression. Part of the characterization of disease or living with a chronic disease may also be informed by patient reported outcome (PRO) measures and care partner surveys.

  15 Years

• To assess safety and effectiveness of disease treatments and treatments for complications of patients receiving various treatments, effectiveness of treatment, and medical events that develop while receiving treatment for ADRD, MCI, PD, or MS.

  The study will evaluate the characteristics of patients receiving various treatments, effectiveness of treatment, and medical events that develop while receiving treatment for ADRD, MCI, PD, or MS. Interval disease and medical events may vary depending on the patient's stage and type of disease and extent of co-morbidities. The progression of pre-existing co-morbidities and variances across populations will also be evaluated. The type, dose and duration of disease-specific therapies will be closely followed with a goal of monitoring treatment paradigms and various combination regimens for clinical response and disease stabilization/progression.

  15 Years

Secondary Outcomes (3)

• To evaluate provider management practices in the treatment of patients living with ADRD, MCI, PD, or MS

  15 Years

• To evaluate longitudinal and patient and care partner reported outcomes in patients with ADRD, MCI, PD, or MS, including care partner burden and quality of life.

  15 Years

• 3. To select and evaluate quality of care measures for patients living with ADRD, MCI, PD, or MS

  15 Years

Other Outcomes (1)

• To evaluate the screening accuracy of a passive digital marker algorithm for early ADRD detection among several different healthcare institutions EHRs

  15 Years

Study Arms (3)

Disease Cohort

Observational

Engaged Cohort

Observational

Age Cohort

Observational

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will include adults who are being managed for ADRD, MCI, PD, or MS as well as patients aged 60 years and older.

You may qualify if:

• Adult patients at the time of enrollment with a diagnosis of ADRD, MCI, PD, or MS by select ICD-10 codes in the EHR interface

You may not qualify if:

• Death
• Manual removal (sponsor or site request)
• No EHR interface encounter \> 3 years
• Engaged Cohort
• Adult patients diagnosed and managed for these conditions invited to participate
• Ability to provide written informed consent (or have a legally authorized representative to provide informed consent)
• Care partners may be invited to participate in surveys and will provide informed consent.
• Patient expressed desire to withdraw consent to complete PROs
• Care partner expressed desire to withdraw consent to complete PROs
• Failure to complete PROs within 24 weeks of initial invitation
• Greater than 24 months lapse of survey completion after baseline surveys completed
• Additionally, the criteria detailed for Disease Cohort apply to the Engaged Cohort
• Age Cohort
• Adult patients aged 60 and older at time of enrollment
• Death

Sponsors & Collaborators

• Target PharmaSolutions, Inc.: lead

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood with serum

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction; Parkinson Disease; Multiple Sclerosis

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2023
• First Posted: April 3, 2023
• Study Start: March 31, 2025
• Primary Completion (Estimated): December 31, 2038
• Study Completion (Estimated): December 31, 2038
• Last Updated: November 20, 2024

Record last verified: 2024-04