Discovering Factors in the Clinical Trial Journey of Dementia Patients

NCT ID: NCT05850000

Last Updated: 2023-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-31

Study Completion Date

2026-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Dementia

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

55 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Power Life Sciences Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael B Gill

Role: STUDY_DIRECTOR

Power Life Sciences Inc.

Central Contacts

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Michael B Gill

Role: CONTACT

415-900-4227

References

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Perng CH, Chang YC, Tzang RF. The treatment of cognitive dysfunction in dementia: a multiple treatments meta-analysis. Psychopharmacology (Berl). 2018 May;235(5):1571-1580. doi: 10.1007/s00213-018-4867-y. Epub 2018 Mar 3.

Reference Type BACKGROUND
PMID: 29502274 (View on PubMed)

Whitehouse PJ, Kittner B, Roessner M, Rossor M, Sano M, Thal L, Winblad B. Clinical trial designs for demonstrating disease-course-altering effects in dementia. Alzheimer Dis Assoc Disord. 1998 Dec;12(4):281-94. doi: 10.1097/00002093-199812000-00007.

Reference Type BACKGROUND
PMID: 9876956 (View on PubMed)

Graham NS, Sharp DJ. Understanding neurodegeneration after traumatic brain injury: from mechanisms to clinical trials in dementia. J Neurol Neurosurg Psychiatry. 2019 Nov;90(11):1221-1233. doi: 10.1136/jnnp-2017-317557. Epub 2019 Sep 21.

Reference Type BACKGROUND
PMID: 31542723 (View on PubMed)

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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94341447

Identifier Type: -

Identifier Source: org_study_id

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