Ignite Creation Date:
2024-05-06 @ 3:11 PM
Last Modification Date:
2024-10-26 @ 1:45 PM
Study NCT ID:
NCT04552795
Status:
COMPLETED
Last Update Posted:
2023-05-16
First Post:
2020-08-11
Brief Title:
Pilot Study to Investigate the Safety and Feasibility of AntiRetroviral Therapy for Alzheimers Disease
Sponsor:
Bess Frost PhD
Organization:
The University of Texas Health Science Center at San Antonio
Study Overview
Official Title:
Pilot Study to Investigate the Safety and Feasibility of AntiRetroviral Therapy for Alzheimers Disease ART-AD
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ART-AD
Brief Summary:
The objective of the study is to evaluate the ability of --L-23-dideoxy-3-thiacytidine 3TC to engage its intended target penetrate the central nervous system CNS suppress neurodegeneration and assess safety and tolerability in patients with early stage Alzheimers disease This study will provide the initial data on target engagement and Alzheimers disease-relevant outcomes for future trials
Detailed Description:
This open label study of 3TC will collect initial proof-of-concept data on 3TC target engagement CNS penetration efficacy and safety in older adults with early stage Alzheimers disease If successful data will be used to design a larger phase 2 clinical trial The investigators aim to I Quantify 3TC target engagement and CNS penetration II Determine if 3TC suppresses Alzheimers disease-relevant outcomes and III Assess the safety and tolerability of 3TC in older individuals with early Alzheimers disease The study will consist of a screeningbaseline period of 30 days pre-treatment a 24-week open label treatment period and a follow up visit one month following treatment Visits to the clinic include a pre-treatment screening visit that includes a comprehensive neuropsychological exam a tablet-based neuropsychological exam and a blood draw For eligible participants a lumbar puncture will be performed on day one of treatment Participants will visit the clinic on day one of treatment and at weeks 8 16 and 24 of treatment to complete medication checks physical examinations tablet-based cognitive screening and blood draw At week 24 of treatment patients will undergo a post-treatment comprehensive neuropsychological exam a lumbar puncture to collect cerebrospinal fluid and a blood draw One month after the final dose of medication participants will return to the clinic for a final safety assessment and disenrollment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None