NCT lookup

Inclusion Criteria:

* Meets National Institute on Aging-Alzheimer's Association clinical diagnostic criteria for mild cognitive impairment (MCI) or AD dementia.
* Has evidence of AD assessed by plasma p-tau217. Prior cerebrospinal fluid (CSF) or positron emission tomography (PET) amyloid testing (obtained clinically or through previous research) from the past 2 years may be used for eligibility with approval from study investigators.
* Clinical Dementia Rating (CDR) global score of 0.5 or 1.
* Mini-Mental State Exam (MMSE) score of 18 to 30 (inclusive).
* 15-item Geriatric Depression Scale (GDS) score of \< 6.
* Impaired memory performance below an education adjusted cut-off score on the Logical Memory II subscale delayed paragraph recall of Wechsler Memory Scale-Revised (WMS-R) (≥16 years: ≤8; 8-15 years: ≤4; 0-7 years: ≤2).
* May take FDA approved medications for the treatment of AD dementia, but if taking such medications, they must be stable for at least 8 weeks before screening (for cholinesterase inhibitors and/or memantine) or 6 months (for lecanemab or donanemab).
* Has adequate visual and auditory acuity to participate in neuropsychological testing and other study outcomes.
* Has availability of a study partner who has regular contact with the participant and knows him/her well.
* Is willing and able to participate in all assessments in English.
* Is capable of providing written informed consent

Exclusion Criteria:

* Neurologic diseases: Neurologic disease other than AD such as Parkinson's disease, vascular dementia, dementia with Lewy bodies, frontotemporal dementia, normal pressure hydrocephalus, corticobasal syndrome, malignant brain tumor (within the last 1 year), multiple sclerosis, or significant head trauma (e.g. with loss of consciousness for 30 minutes or more) followed by persistent neurologic deficits, or significant structural brain abnormalities.
* Neuroimaging: Magnetic resonance imaging (MRI) scan evidence of cortical stroke or macrohemorrhage (\>1 cm), strategically located lacunar stroke, or severe small vessel disease.
* Alcohol or substance use disorder or dependence (Diagnostic and Statistical Manual of Mental Disorders version 5 \[DSM 5\] criteria) within the last 2 years.
* Untreated major depressive disorder (within the last 1 year), bipolar disorder, schizophrenia (DSM 5 criteria), or current major psychotic symptoms or behavioral problems.
* Any systemic illness or unstable medical conditions, which could affect valid cognitive and self-report assessments.
* Excluded medications: Antipsychotic medications; antidepressant medications with anticholinergic side effects. Washout from psychoactive medications for at least 8 weeks before screening.
* Laboratory abnormalities: AST or ALT \> 3 times the upper limit of normal; creatinine clearance \<60 mL/min; HbA1C \> 8.5%.
* Participation in an investigational trial within the past 3 months or 5 half-lives, whichever is shorter
* Conditions which, in the opinion of the investigator, would jeopardize safety or impact the validity of the study results.
* Person who is positive for HBV Surface Antigen.
* Person with a history of osteoporosis or osteomalacia.
* Person taking FTC-TDF for pre-exposure prophylaxis or treatment of HIV.

• Boston, Massachusetts, United States