Neurological Diseases or ConditionsNCT05796037
An Observational Study of Patients Living With Chronic Neurological Diseases
An observational study of Neurological Diseases or Conditions and Dementia of Alzheimer Type, run by Target PharmaSolutions, Inc..
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurological Diseases or Conditions, Dementia of Alzheimer Type, Alzheimer Disease
- How many people
- 1,500,000 participants
- Where
- No sites listed yet
- Study dates
- 31 Mar 2025to 31 Dec 2038
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: The study will include adults who are being managed for ADRD, MCI, PD, or MS as well as patients aged 60 years and older.
Who may be able to join
- •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
- 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.
- •Adult patients aged 60 and older at time of enrollment
Who cannot join
- Death
- Manual removal (sponsor or site request)
- No EHR interface encounter > 3 years
- Engaged Cohort
- Patient expressed desire to withdraw consent to complete PROs
- Care partner expressed desire to withdraw consent to complete PROs
Show all 13Show fewer
- 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
- Death
- Manual removal (sponsor or site request)
- No EHR interface encounter > 3 years
About this study
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
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction, Parkinson Disease, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Disease Cohort | Observational | |
| Engaged Cohort | Observational | |
| Age Cohort | Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 15 Years
Secondary outcomes (3)
To evaluate provider management practices in the treatment of patients living with ADRD, MCI, PD, or MS
Health care provider type, clinic setting, reason for initiating/not initiating/adjusting dosing of treatments, reason for discontinuing/switching treatments, and monitoring outcomes on and off treatment, will be captured as available in the provided EHR and/or through linked data. Disease-specific quality measures will be selected and evaluated
Measured: 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.
Longitudinal clinical outcomes and disease progression will be assessed. Self and proxy-reported patient health measures collect information directly from patients or their informants to measure physical, mental, and social health. These measures can help clinicians better understand how the disease state and/or various treatments affect what patients are able to do and the symptoms they experience beyond what is typically derived and reported in the EHR as part of traditional clinical evaluations. The information can also be used to help patients make informed decisions about their healthcare and treatment options. Care partner surveys can help define the prevalence and needs of care partners who provide support and care to people living with ADRD, MCI, PD, and MS.
Measured: 15 Years
3. To select and evaluate quality of care measures for patients living with ADRD, MCI, PD, or MS
- Identify deficiencies and best practices in care of patients living with neurological diseases
- Develop a technology infrastructure to evaluate quality measures to support clinicians and clinical decision making
Measured: 15 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start31 Mar 2025 (estimated)
- Primary completion31 Dec 2038 (estimated)
- Study completion31 Dec 2038 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurological Diseases or ConditionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Enrolment
- 1,500,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Target PharmaSolutions, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05796037
- Sponsor's protocol ID
- TARGET-NEURO
- Status last verified
- Apr 2024
- First submitted
- 9 Mar 2023
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study of Patients Living With Chronic Neurological Diseases
- ClinicalTrials.gov ID
- NCT05796037
- Acronym / sponsor ID
- TARGET-NEURO
- Conditions
- Neurological Diseases or Conditions, Dementia of Alzheimer Type, Alzheimer Disease, Mild Cognitive Impairment, Parkinson Disease, Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,500,000 participants (estimated)
- Lead sponsor
- Target PharmaSolutions, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Mar 2025 (estimated)
- Primary completion
- 31 Dec 2038 (estimated)
- Study completion
- 31 Dec 2038 (estimated)
- First posted
- 3 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Disease Cohort | – | –Observational |
| Engaged Cohort | – | –Observational |
| Age Cohort | – | –Observational |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- •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
- 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.
- •Adult patients aged 60 and older at time of enrollment
Key exclusion criteria (13 listed)
- Death
- Manual removal (sponsor or site request)
- No EHR interface encounter > 3 years
- Engaged Cohort
- Patient expressed desire to withdraw consent to complete PROs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To characterize the natural history of disease in patients living with chronic neurological diseases including ADRD, MCI, PD, or MS
Time frame: 15 Years
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.
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.
Time frame: 15 Years
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.
3 secondary outcomes
To evaluate provider management practices in the treatment of patients living with ADRD, MCI, PD, or MS
Time frame: 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.
Time frame: 15 Years
3. To select and evaluate quality of care measures for patients living with ADRD, MCI, PD, or MS
Time frame: 15 Years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurological Diseases or Conditions and Dementia of Alzheimer Type, run by Target PharmaSolutions, Inc..
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 5 inclusion and 13 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: opening soon, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
To characterize the natural history of disease in patients living with chronic neurological diseases including ADRD, MCI, PD, or MS (time frame: 15 Years). 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 20 Nov 2024.