Discovering Factors in the Clinical Trial Journey of Dementia Patients

Dementia Clinical Trial

Official title:

Dementia Clinical Trials: A Study on the Clinical Trial Participation of Dementia Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05850000
• Other study ID #: 94341447
• Status: Not yet recruiting
• Start date: May 2024
• Est. completion date: May 2026

Study information

• Verified date: April 2023
• Source: Power Life Sciences Inc.
• Contact: Michael B Gill
• Phone: 415-900-4227
• Email: bask[@]withpower.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: May 2026
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Dementia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Power Life Sciences Inc.

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of patients who decide to enroll in a dementia clinical study.		3 months
Primary	Number of dementia patients who remain in clinical trial until completion.		12 months