Clinical trial NCT06218732: Revealing Engagement Dynamics Among Semantic Dementia Patients
Official title: Understanding Participation Habits: An Observational Investigation Within Semantic Dementia Clinical Trials
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Semantic Dementia
Keywords: Semantic Dementia
Lead sponsor: Power Life Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2024-01-23
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with semantic dementia who are actively considering enrolling in a clinical trial for said condition, but have not yet completed enrollment and randomization phases.

Brief summary: The study intends to investigate the personal experiences of semantic dementia patients who take part in a separate clinical study including a specific medication intervention. The major focus will be on closely following individuals' rates of trial completion and withdrawal.

The data collected from this study will help improve future outcomes for all semantic dementia as well as those in under-represented demographic groups.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with semantic dementia
* Aged ≥ 18 years old and ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed
* Subjects willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examination.

Exclusion Criteria:

* Refusal of consent
* Women of childbearing potential without a negative pregnancy test; or women who are lactating.
* Any serious and/or unstable pre-existing medical disorders

Primary outcomes:
measure: Rate of patients who decide to enroll in a semantic dementia clinical research.
timeFrame: 3 months
measure: Number of semantic dementia study participants who remain in clinical study until completion.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Power Life Sciences
state: California
Study officials:
affiliation: Power Life Sciences Inc.
name: Michael B Gill
role: STUDY_DIRECTOR
References:
citation: Paplikar A, Vandana VP, Mekala S, Darshini KJ, Arshad F, Iyer GK, Kandukuri R, Divyaraj G, Varghese F, Kaul S, Patterson K, Alladi S. Semantic memory impairment in dementia: A cross-cultural adaptation study. Neurol Sci. 2022 Jan;43(1):265-273. doi: 10.1007/s10072-021-05272-5. Epub 2021 May 8.
citation: Kertesz A, Jesso S, Harciarek M, Blair M, McMonagle P. What is semantic dementia?: a cohort study of diagnostic features and clinical boundaries. Arch Neurol. 2010 Apr;67(4):483-9. doi: 10.1001/archneurol.2010.55.
citation: Sato S, Hashimoto M, Yoshiyama K, Kanemoto H, Hotta M, Azuma S, Suehiro T, Kakeda K, Nakatani Y, Umeda S, Fukuhara R, Takebayashi M, Ikeda M. Characteristics of behavioral symptoms in right-sided predominant semantic dementia and their impact on caregiver burden: a cross-sectional study. Alzheimers Res Ther. 2021 Oct 9;13(1):166. doi: 10.1186/s13195-021-00908-2.