Revealing Engagement Dynamics Among Semantic Dementia Pat... | NCT06218732

Studies
Revealing Engagement Dynamics Among Semantic Dementia Patients

NCT06218732

Sponsor

Power Life Sciences Inc.

Status

Not yet recruiting

Last Update Posted

Jan 23, 2024Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Semantic Dementia

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2024

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2025Estimated

Primary Completion Date

Feb 2026Estimated

Completion Date

Feb 2027Estimated

First Submitted Date

Jan 12, 2024

First Submission Date that Met QC Criteria

Jan 12, 2024

First Posted Date

Jan 23, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 12, 2024

Last Update Posted Date

Jan 23, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rate of patients who decide to enroll in a semantic dementia clinical research.		3 months
Number of semantic dementia study participants who remain in clinical study until completion.		12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Michael B Gill	Contact	(415) 900-4227		bask@withpower.com

Overall Officials

Name	Affiliation	Role
Michael B Gill	Power Life Sciences Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Power Life Sciences		San Francisco	California	94107	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33966130	Background	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.
20385916	Background

ID	Term
D057174	Frontotemporal Lobar Degeneration
D003704	Dementia
D001927	Brain Diseases
D002493	Central Nervous System Diseases