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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 belowSelect...
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.
LINE-AD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to the follow up study visit (7-8 months after first treatment)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to the follow up study visit (7-8 months after first treatment)
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 moreLINE-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
16,358 Total Patients Enrolled
Alzheimer's AssociationOTHER
92 Previous Clinical Trials
40,876 Total Patients Enrolled
Brown UniversityOTHER
456 Previous Clinical Trials
558,221 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- Your cerebrospinal fluid (CSF) test must show a pTau/Aβ42 ratio of more than 0.024.I do not have any conditions affecting my thinking or memory.I am between 50 and 85 years old.Your brain MRI shows something that could cause future memory problems, could be risky for you, or could make it hard to monitor your safety during the study.I have been diagnosed with mild cognitive impairment or mild dementia due to Alzheimer's disease.Your score on the Mini Mental State Exam (MMSE) is between 15 and 30.In the past six months, you have had thoughts of suicide or have engaged in suicidal behavior in the past two years.I have been on a stable dose of cholinesterase inhibitors and memantine for at least 60 days.You have mild to severe dementia, as measured by the Clinical Dementia Rating (CDR) scale.
Research Study Groups:
This trial has the following groups:- Group 1: Group 1
- Group 2: Group 2
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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