← Back to Search

Nucleoside Reverse Transcriptase Inhibitor

Emtricitabine for Alzheimer's Disease (LINE-AD Trial)

Phase 1
Recruiting
Led By Stephen Salloway, MD
Research Sponsored by Butler Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female, ages 50-85 years inclusive
Must meet NIA-AA research criteria for MCI and mild dementia due to AD
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to the follow up study visit (7-8 months after first treatment)
Awards & highlights

LINE-AD Trial Summary

This trial will study whether a daily oral dose of 200 mg emtricitabine can help improve memory in people with mild to moderate dementia due to Alzheimer's disease.

Who is the study for?
This trial is for people aged 50-85 with mild cognitive impairment or mild to moderate dementia due to Alzheimer's, confirmed by specific biomarkers. Participants need a reliable study partner and must have been on stable doses of certain Alzheimer's medications for at least 60 days. Exclusions include other significant neurological conditions, recent drug abuse, major organ toxicity risk from other drugs, severe heart/liver/kidney disease, pregnancy/breastfeeding, and certain psychiatric risks.Check my eligibility
What is being tested?
The trial tests the effectiveness of Emtricitabine (200 mg daily) against a placebo in improving cognitive function over approximately one year. It involves participants who meet specific criteria related to Alzheimer's Disease and includes regular monitoring through visits and follow-ups.See study design
What are the potential side effects?
While not specified here, common side effects of nucleoside reverse transcriptase inhibitors like Emtricitabine can include headache, nausea, diarrhea, fatigue and potential changes in liver enzymes or blood cell counts.

LINE-AD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 50 and 85 years old.
Select...
I have been diagnosed with mild cognitive impairment or mild dementia due to Alzheimer's disease.
Select...
I have been on a stable dose of cholinesterase inhibitors and memantine for at least 60 days.

LINE-AD Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to the follow up study visit (7-8 months after first treatment)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to the follow up study visit (7-8 months after first treatment) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with treatment emergent adverse events (TEAE's) in the treatment group will be compared to the placebo group
Secondary outcome measures
Change from baseline in Alzheimer's Disease Assessment Scale-cognitive (ADAS-Cog -13)
Change from baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL)
Change from baseline in Clinical Dementia Rating (CDR)
+4 more

LINE-AD Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Group 1Active Control1 Intervention
25 MCI and mild to moderate AD subjects
Group II: Group 2Placebo Group1 Intervention
10 MCI and mild to moderate AD subjects

Find a Location

Who is running the clinical trial?

Butler HospitalLead Sponsor
129 Previous Clinical Trials
16,383 Total Patients Enrolled
Alzheimer's AssociationOTHER
89 Previous Clinical Trials
40,728 Total Patients Enrolled
Brown UniversityOTHER
454 Previous Clinical Trials
562,776 Total Patients Enrolled

Media Library

Emtricitabine (Nucleoside Reverse Transcriptase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04500847 — Phase 1
Alzheimer's Disease Research Study Groups: Group 1, Group 2
Alzheimer's Disease Clinical Trial 2023: Emtricitabine Highlights & Side Effects. Trial Name: NCT04500847 — Phase 1
Emtricitabine (Nucleoside Reverse Transcriptase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04500847 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants have enrolled in the experiment thus far?

"Affirmative, the information on clinicaltrials.gov affirms that this experiment is actively recruiting participants. Initially posted in December 2021 and most recently updated September 2022, the research seeks to enrol 35 individuals across a single medical centre."

Answered by AI

Are there any criteria that would disqualify me from participating in this research?

"In order to qualify for participation in this clinical trial, candidates must have experienced cognitive decline and be aged between 50-85. The research is currently seeking 35 test subjects."

Answered by AI

How is Group 1 regularly deployed in medical treatments?

"Group 1 is primarily used to treat HIV, AIDS, and other related diseases. It has been approved for use in treating human immunodeficiency virus type one (HIV-1) infections as well as preventing the transmission of the disease."

Answered by AI

Does this research trial accept participants who are senior citizens?

"The requirements to partake in this medical trial are that the applicant is aged between 50 and 85. There are 979 trials for persons over 65 years old, while 55 clinical studies exist tailored specifically for individuals under 18 years of age."

Answered by AI

Is there currently an opportunity for participants to join this research project?

"Evidenced by the clinicaltrials.gov data, this scientific exploration is open to volunteers. The trial was initially advertised on December 17th 2021 and has been modified most recently in September 14th 2022."

Answered by AI

Has there been prior experimentation involving Group 1?

"Presently, 61 research initiatives concerning Group 1 are taking place. Of the active trials, 18 have progressed to Phase 3 of clinical testing. The majority of studies for Group 1 are located in Boylston, Massachusetts; however there is a total of 871 sites conducting these experiments all over the world."

Answered by AI

What potential risks can individuals incur by being exposed to Group 1?

"Due to the scarcity of clinical evidence, Group 1 was assigned a score of 1 for safety. This is because this trial falls into Phase I, indicating minimal data on both efficacy and risk mitigation."

Answered by AI

Who else is applying?

What site did they apply to?
Memory and Aging Program, Butler Hospital
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I was in the aducanumab study that ended in 2023.
PatientReceived no prior treatments
~0 spots leftby Mar 2024