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Study Details
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Description
Eligibility Requirements
Inclusion Criteria:
Male or female participants aged 55 to 80 years of age at the time of signing the informed consent form
Mild cognitive impairment or mild dementia consistent with AD defined by stages 3 to 4 according to the NIA AA at Screening
Participants with a history of subjective cognitive and memory decline with onset within 3 years before Screening, confirmed by study partner.
Participants who have a MMSE Score greater than or equal to 20
Participants with a CDR global rating of 0.5 or 1
Participants with a RBANS score less than or equal to 85 based on the Delayed Memory Index (DMI) score
Participants who have had a magnetic resonance imaging (MRI) or computer tomography (CT) scan performed after onset of symptoms and within 2 years prior to screening with findings consistent with the diagnosis of AD and without any other clinically significant comorbid pathologies
Confirmed amyloid beta pathology by cerebrospinal fluid (CSF) analysis
Exclusion Criteria:
Participants who are female and are either pregnant, nursing, or of childbearing potential and not practicing effective contraception
Participants who have signs of delirium
Participants who have any diagnosis of dementia or cognitive decline other than that related to Alzheimer's disease, including, but not limited to concomitant history of significant head trauma, alcohol abuse, frontotemporal dementia, Huntington Disease, and Parkinsonism (e.g., Parkinson's disease, Dementia with Lewy Bodies, etc.)
Participants with any current psychiatric diagnosis if, in the judgment of the investigator, the psychiatric disorder (e.g., schizophrenia) or symptom is likely to confound interpretation of drug effect, affect cognitive assessments, or affect the participant's ability to complete the study
Participants with vascular dementia and/or a Hachinski Ischemic Scale (HIS) score ≥7
Participants with a recent MRI with evidence of central nervous system (CNS) infection, cerebrovascular (CBV) disease, or other neurological disease thought to interfere with the evaluations in this study
Participants with a history of myocardial infarction, unstable angina, coronary artery disease, or New York Heart Association (NYHA) class III or IV heart failure within the last 12 months
Participants with uncontrolled hypertension (systolic blood pressure >160 mmHg or diastolic blood pressure > 95 mmHg) or hypotension (systolic blood pressure <90 mmHg or diastolic blood pressure <50 mmHg). Participants may undergo repeated testing to ensure that accurate blood pressure readings are obtained
Participants with a body mass index (BMI) > 35 kg/m2
Participants who have any other clinically significant abnormal laboratory tests such as elevated aspartate aminotransferase (AST), alanine transaminase (ALT), or total bilirubin levels, or abnormally low vitamin B12, high TSH levels, or evidence of folic acid deficiency, as determined by the Investigator
Participants who have history of cancer or malignant tumor within 5 years prior to screening with the exception of:
- Basal or squamous cell carcinoma of the skin or cervical dysplasia, which has been adequately treated
- In situ Grade 1 cervical cancer, fully treated at least 2 years prior to screening, and without recurrence.
- Prostate cancer, confined to the prostate gland, which has been adequately treated (surgery and/or radiation) with normal or low and stable PSA levels for 2 years prior to Screening
- Adequately treated non-metastatic breast cancer
Participants who have history of untreated thyroid disorder
Participants with inherited degenerative retinal disease
Participants who have an undiagnosed or uncontrolled seizure disorder (and/or an epileptic syndrome), which has or could lead to cognitive impairment either from repeated seizures or the medications used to control the seizure disorder
Participants who are being treated, or likely to require treatment during the study, with any medications prohibited by the study protocol
Principal Investigator
Co-Investigator(s)
Minal Bhanushali, MD, PAMFRI Medical Director
Funder
AriBio USA, Inc
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