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

Must not have

Current medical or neurological condition that might impact cognition or performance on cognitive assessments, e.g., Huntington's disease, Parkinson's disease, syphilis, schizophrenia, bipolar disorder, active major depression, attention deficit/ hyperactivity disorder (ADD/ADHD), multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS), active seizure disorder, current alcohol/drug abuse or dependence, or dependence within the last two years, or history of traumatic brain injury associated with loss of consciousness and ongoing residual transient or permanent neurological signs/symptoms including cognitive deficits, and/or associated with skull fracture

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to the follow up study visit (7-8 months after first treatment)

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 50 and 85 years old.

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I have been diagnosed with mild cognitive impairment or mild dementia due to Alzheimer's disease.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any conditions affecting my thinking or memory.

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)

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.