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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06218732
Other study ID # 58672364
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date February 2025
Est. completion date February 2027

Study information

Verified date January 2024
Source Power Life Sciences Inc.
Contact Michael B Gill
Phone (415) 900-4227
Email bask@withpower.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 500
Est. completion date February 2027
Est. primary completion date February 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Locations

Country Name City State
United States Power Life Sciences San Francisco California

Sponsors (1)

Lead Sponsor Collaborator
Power Life Sciences Inc.

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

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