Repurposing Nucleoside Reverse Transcriptase Inhibitors for Treatment of AD
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age50-85
SponsorButler Hospital
About this trial
This is a randomized, double-blind clinical trial of a daily oral dose of 200 mg emtricitabine vs. placebo in 35 participants with biomarker-confirmed MCI or mild to moderate dementia due to Alzheimer's disease. Study duration for each subject participating in the placebo-controlled research study will be approximately 12 months (up to a 3 months Screening Period, Baseline visit (1 month), 6 months of placebo or emtricitabine dosing, and 1 month follow-up). Participants will have up to 2 months to complete all procedures for the month 6 study visit.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female, ages 50-85 years inclusive
Intellectually, visually and auditory capable, fluent in, and able to read, the language in which study assessments are administered (e.g. completion of at least six years of regular schooling or sustained employment or equivalent local level of knowledge).
Must meet NIA-AA research criteria for MCI and mild dementia due to AD
Mini Mental State Exam (MMSE) 15-30 inclusive
Disqualifiers
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
Brain MRI results showing findings unrelated to AD that, in the opinion of the investigator might be a leading cause of future cognitive decline, might pose a risk to the participant, or might confound MRI assessment for safety monitoring
Score "yes" on item four or item five of the Suicidal Ideation section of the Columbia Suicide Severity Rating Scale (eC-SSRS patient-reported outcome), if this ideation occurred in the past six months, or "yes" on any item of the Suicidal Behavior section, except for the "Non-Suicidal Self-Injurious Behavior" (item is included in the Suicidal Behavior section), if this behavior occurred in the past 2 years prior to screening
Small molecules: after five half-lives, or within 30 days until the expected pharmacodynamic effect has returned to baseline, whichever is longer
Trial design
Design model
Parallel
Treatments tested in this trial
Emtriva Capsule
Drug200mg daily oral dose
Placebo
Drug200mg daily oral dose
Treatment groups
35 Participants
are divided into 2 treatment groupsGroup A: Group 1Active comparator 1 intervention
Group B: Group 2Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Number of participants with treatment emergent adverse events (TEAE's) in the treatment group will be compared to the placebo group
Number of participants with treatment emergent adverse events and serious adverse events as assessed by CTCAE (Version 4.03).
Time frame
Baseline to the follow up study visit (7-8 months after first treatment)Secondary outcomes
1
Change from baseline in key inflammatory biomarkers; Tumor necrosis factor-alpha (TNF-α), Interleukin 1-beta (IL-1β), and Interferon-alpha (IFN-α)
Blood draws will be taken from baseline to the follow up study visit. Inflammation and discovery research assays to detect levels of TNF-α, IL-1β, and IFN-α will be performed at Brown University.
Time frame
Baseline to the follow up study visit (7-8 months after first treatment)2
Change in Mini Mental State Examination (MMSE) Total Scores
To determine changes of the MMSE scores from the screening phase to 6 months after first treatment.
Time frame
Screening phase, month 3 and month 6 after first treatment3
Change from baseline in Clinical Dementia Rating (CDR)
To determine changes of CDR scores from screening phase to 6 months after first treatment.
Time frame
Screening phase, month 3 and 6 months after first treatment4
Change from baseline in Alzheimer's Disease Assessment Scale-cognitive (ADAS-Cog -13)
To determine changes in ADAS-Cog scores from screening phase to 6 months after first treatment.
Time frame
Screening phase, month 3 and month 6 after first treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Butler Hospital
Lead sponsor
Alzheimer's Association
Collaborator
Brown University
Collaborator
The Miriam Hospital
Collaborator
Cedars Sinai Medical Center, Los Angeles, USA
Collaborator
Source ClinicalTrials.gov