Discovering Factors in the Clinical Trial Journey of Dementia Patients

NCT05850000 | Not Yet Recruiting

• 1 other identifier: 94341447
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dementia

Keywords

dementia

Outcome Measures

Primary Outcomes (2)

• Rate of patients who decide to enroll in a dementia clinical study.

  3 months

• Number of dementia patients who remain in clinical trial until completion.

  12 months

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with dementia who are actively considering involvement in an observational clinical trial, but have not yet completed enrollment and registration.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Power Life Sciences Inc.: lead

Related Publications (3)

• 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.

  PMID: 29502274 BACKGROUND

• 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.

  PMID: 9876956 BACKGROUND

• 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.

  PMID: 31542723 BACKGROUND

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Michael B Gill

  Power Life Sciences Inc.

  STUDY DIRECTOR

Central Study Contacts

Michael B Gill

CONTACT

415-900-4227; bask@withpower.com

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2023
• First Posted: May 9, 2023
• Study Start: May 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2026
• Last Updated: May 9, 2023

Record last verified: 2023-04