Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

The A-LIST WMM Insights Series

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04466722
Recruitment Status : Recruiting
First Posted : July 10, 2020
Last Update Posted : July 10, 2020
Sponsor:
Information provided by (Responsible Party):
UsAgainstAlzheimer's

Brief Summary:
The main purpose of the Study is to develop an understanding over time and through multiple research projects, including surveys, interviews, online focus groups, and other primary research methodologies (A-LIST Research Projects) on what matters most to individuals concerned about brain health and those with and/or affected by Alzheimer's disease and other dementias, including caregivers.

Condition or disease
Alzheimer Disease Dementia Mild Cognitive Impairment

Detailed Description:

To do this, UsAgainstAlzheimer's will identify and engage individuals who want to focus on brain health; individuals who are worried about their cognition; individuals who perceive themselves to be at risk for Alzheimer's disease (AD); individuals who may be at risk for AD due to self-identified confirmation of underlying disease pathology; individuals who self-identify as having a diagnosis of mild cognitive impairment (MCI) or of AD or another dementia; and those who self-identify as current or former caregivers of patients with Alzheimer's disease or another dementia to participate in the A-LIST Research Projects. Such participants will either already be - or will be invited to become - members of the A-LIST cohort, an online cohort of individuals ready and willing to engage in A-LIST WMM Insights Series (A-LIST members).

The A-LIST WMM Insights Series will enlist participants to offer insights into a range of issues relevant to Alzheimer's, including as examples issues pertinent to clinical trial design, regulatory submissions, other research strategies, payer value determinations, and care and services research. The A-LIST WMM Insights Series may seek information that in some instances will be marketing research or other research exempt from IRB oversight. However, when an individual A-LIST Research Project constitutes human subjects research consistent with governing law, IRB approval will be sought and obtained. Where questions exist whether an individual A-LIST Research Project constitutes human subject research, IRB determination will be solicited.

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: A-LIST What Matters Most Insights Series
Actual Study Start Date : August 15, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Phenotypical Characteristics of Patients and Caregivers [ Time Frame: 3 years ]
    Online monthly surveys capture the burden and unmet needs for patients and caregivers of individuals with or at risk for Alzheimer's disease, other dementias, and mild cognitive impairment; also recruiting individuals interested in brain health.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Individuals who want to focus on brain health; individuals who are worried about their cognition; individuals who perceive themselves to be at risk for Alzheimer's disease (AD); individuals who may be at risk for due to self-identified confirmation of underlying disease pathology; individuals who self-identify as having a diagnosis of mild cognitive impairment (MCI) or of AD or another dementia; and those who self-identify as current or former caregivers of patients with Alzheimer's disease or another dementia.
Criteria

Inclusion Criteria:

To be eligible to participate in the Study, an individual must meet all of the following criteria:

  1. Age 18 years or older.
  2. United States, Canada resident.
  3. Self-report of cognitive difficulties, caregiver status or interest in brain health.
  4. Have indicated willingness to participate by selecting "I Agree" option when joining the A-LIST. Additionally, will have clicked on link - invitation to take a specific survey
  5. Able to speak, read, and understand English.

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this Study:

1. Unable to comply with the Study requirements.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04466722


Contacts
Layout table for location contacts
Contact: Virginia Biggar, BA 3014521123 vbiggar@usagainstalzheimers.org
Contact: Theresa Frangiosa, MBA 908-872-5815 tfrangiosa@usagainstalzheimers.org

Locations
Layout table for location information
United States, District of Columbia
UsAgainstAlzheimer's Recruiting
Washington, District of Columbia, United States, 20043
Contact: Virginia Biggar, BA    301-452-1123    vbiggar@usagainstalzheimers.org   
Principal Investigator: Theresa Frangiosa, MBA         
Sponsors and Collaborators
UsAgainstAlzheimer's
Investigators
Layout table for investigator information
Principal Investigator: Theresa Frangiosa, MBA UsAgainstAlzheimer's
Additional Information:
Layout table for additonal information
Responsible Party: UsAgainstAlzheimer's
ClinicalTrials.gov Identifier: NCT04466722    
Other Study ID Numbers: A-LIST Protocol 1
First Posted: July 10, 2020    Key Record Dates
Last Update Posted: July 10, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by UsAgainstAlzheimer's:
Alzheimer
Dementia
Cognitive
Cognition
Brain health
Additional relevant MeSH terms:
Layout table for MeSH terms
Alzheimer Disease
Dementia
Cognitive Dysfunction
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders