Clinical trial NCT05796037: An Observational Study of Patients Living With Chronic Neurological Diseases
Official title: An Observational Study of Patients Living With Chronic Neurological Diseases
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Neurological Diseases or Conditions
Dementia of Alzheimer Type
Alzheimer Disease
Mild Cognitive Impairment
Parkinson Disease
Multiple Sclerosis
Lead sponsor: Target PharmaSolutions, Inc.
Sponsor class: INDUSTRY
First posted: 2023-04-03
Enrollment: 1500000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

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).


Eligibility criteria: Disease Cohort

Inclusion Criteria:

•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

Exclusion Criteria:

* Death
* Manual removal (sponsor or site request)
* No EHR interface encounter \> 3 years

Engaged Cohort

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Inclusion Criteria:

•Adult patients aged 60 and older at time of enrollment

Exclusion Criteria:

* Death
* Manual removal (sponsor or site request)
* No EHR interface encounter \> 3 years

Primary outcomes:
measure: To characterize the natural history of disease in patients living with chronic neurological diseases including ADRD, MCI, PD, or MS
timeFrame: 15 Years
measure: 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.
timeFrame: 15 Years
Secondary outcomes:
measure: To evaluate provider management practices in the treatment of patients living with ADRD, MCI, PD, or MS
timeFrame: 15 Years
measure: 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.
timeFrame: 15 Years
measure: 3. To select and evaluate quality of care measures for patients living with ADRD, MCI, PD, or MS
timeFrame: 15 Years
Other outcomes:
measure: To evaluate the screening accuracy of a passive digital marker algorithm for early ADRD detection among several different healthcare institutions EHRs
timeFrame: 15 Years
Locations:
Study officials:
References: