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Discovering Factors in the Clinical Trial Journey of Dementia Patients

Sponsor
Power Life Sciences Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05850000
Collaborator
(none)
500
Enrollment
24
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This research aims to collect comprehensive data on the clinical trial experience of dementia patients. Its goal is to identify the factors that limit patients' ability to join or complete a trial successfully. Clinical trial participation often favors specific demographic groups, and limited research exists on the impact of trial attributes on participation. Therefore, this study aims to analyze data from various demographic groups and identify any recurring trends that could provide valuable insights for future dementia patients.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Case-Crossover
    Time Perspective:
    Prospective
    Official Title:
    Dementia Clinical Trials: A Study on the Clinical Trial Participation of Dementia Patients
    Anticipated Study Start Date :
    May 1, 2024
    Anticipated Primary Completion Date :
    May 1, 2025
    Anticipated Study Completion Date :
    May 1, 2026

    Outcome Measures

    Primary Outcome Measures

    1. Rate of patients who decide to enroll in a dementia clinical study. [3 months]

    2. Number of dementia patients who remain in clinical trial until completion. [12 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    55 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed.

    • Participant has a diagnosis of dementia.

    • Willing and able to comply with scheduled visits, treatment schedule, laboratory tests and other requirements of the study.

    Exclusion Criteria:

    • Pregnant or lactating woman

    • Enrolled in another research study

    • Any mental or medical condition that prevents the patient from giving informed consent or participating in the trial

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Power Life Sciences Inc.

    Investigators

    • Study Director: Michael B Gill, Power Life Sciences Inc.

    Study Documents (Full-Text)

    More Information

    Publications

    Responsible Party:
    Power Life Sciences Inc.
    ClinicalTrials.gov Identifier:
    NCT05850000
    Other Study ID Numbers:
    • 94341447
    First Posted:
    May 9, 2023
    Last Update Posted:
    May 9, 2023
    Last Verified:
    Apr 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Power Life Sciences Inc.
    dementia
    Additional relevant MeSH terms:
    Dementia

    Study Results

    No Results Posted as of May 9, 2023