Start: October 4, 2018
End: December 31, 2020
What Is This Study About?
This Phase II trial will test the safety, tolerability, and effects of AD-35 on cognitive function in older adults with mild to moderate Alzheimer's disease.
Do I Qualify To Participate in This Study?
- Diagnosis of probable Alzheimer's disease
- Mini-Mental State Examination score of 15 to 26
- Magnetic resonance imaging (MRI) consistent with diagnosis of probable Alzheimer's disease
- Caregiver with face-to-face and/or telephone contact at least three times per week who can oversee taking of the study drug and participate in assessments
- No previous amyloid- or tau-based treatment for Alzheimer's
- If taking Alzheimer's drugs (galantamine, donepezil, rivastigmine, or memantine), must be off therapy for at least 3 months before baseline or only just started therapy within 7 days
- If taking medications that might affect cognitive function, such as non-anticholinergic antidepressants, atypical antipsychotics, or centrally acting anticholinergic antihistamines, must be at a stable dose for 1 month prior to randomization and throughout study; short-term or occasional treatment must be past 5 half-lives at time of assessments
- Women must be postmenopausal for at least 2 years or surgically sterile for at least 6 months
- Men with partners of reproductive potential must agree to use a reliable means of contraception during the study and 30 days after stopping the study drug
- Able to read, write, speak, and understand English (both person with Alzheimer's and his or her caregiver)
- Weigh between 99 and 198 pounds
- General good health based on medical history, physical exam, vital signs, electrocardiogram, and lab results
Must NOT have:
- Lack of access to veins
- Uncorrected vision or hearing impairments that would interfere with test taking
- Inability to undergo MRI, including magnetic, electronic, or mechanical implants
- Severe or unstable medical condition that would interfere with ability to complete study assessments
- History or presence of clinically evident vascular disease potentially affecting the brain (e.g., stroke, clinically significant carotid or vertebral stenosis or plaque, aortic aneurysm, intracranial aneurysm, cerebral hemorrhage, and arteriovenous malformation)
- History of severe central nervous system trauma, such as cerebral contusion
- History or presence of intracranial tumor (e.g., meningioma and glioma), infections that affect brain function or the central nervous system (e.g., syphilis, neuroborreliosis, viral or bacterial meningitis/encephalitis, and HIV encephalopathy), or systemic autoimmune disorders potentially causing progressive neurologic disease (e.g., multiple sclerosis, lupus erythematosus, anti-phospholipid antibody syndrome, and Behet disease)
- Psychiatric disease that may affect cognition or interfere with study, including schizophrenia, bipolar disorder, and major depression (except if no episode of major depression within past 5 years)
- Neurologic disease other than Alzheimer's that may affect cognition (e.g., Parkinson's disease, corticobasal degeneration, dementia with Lewy bodies, Creutzfeldt-Jakob disease, progressive supranuclear palsy, frontotemporal degeneration, Huntington's disease, normal pressure hydrocephalus, and hypoxia)
- History of seizures with the exception of childhood febrile seizures
- Alcohol or drug abuse within past 5 years
- Evidence of malignancies, acute infections, kidney failure that requires dialysis, or other unstable medical disease (except for cancers with a low probability of recurrence or not being actively treated with anti-cancer drugs or radiotherapy)
- History or presence of atrial fibrillation that poses a risk for future stroke
- Severe heart disease, including heart attack, congestive heart disease, and unstable angina pectoris within past 6 months
- Clinically significant vital signs, laboratory, or electrocardiogram abnormalities
- Estimated glomerular filtration rate of less than 30 mL/min/1.73 m2
- Impaired liver function
- Evidence of poorly controlled diabetes
- Superficial siderosis of the central nervous system, more than 4 small chronic brain hemorrhages, or evidence of a prior large brain hemorrhage
- Significant cerebral vascular pathology as assessed by MRI
- Treatment with any investigational agent within 5 half-lives or 4 weeks prior to screening, whichever is longer
- Treatment with any biologic therapy within 5 half-lives or 3 months prior to screening, whichever is longer, or participation in an amyloid or tau vaccination trial unless received placebo
- Cognitive dysfunction that might be due to past or current medication
- Prohibited medications: anticholinergic antidepressants, typical antipsychotics, or barbiturates; chronic use of opiates, opioids, or benzodiazepines (intermittent short-term use allowed except within 5 half-lives of neurocognitive assessments)
- Use or intention to use any medications or products that are certain substrates of the enzyme cytochrome P450 3A4 (abbreviated CYP3A4)
- Use or intention to use any medications or products that are known to be strong inducers/inhibitors of CYP3A4 within 7 days of first dose and throughout study drug administration
- Consumption of grapefruit juice or grapefruit-containing products within 7 days of first dose and throughout study drug administration
If I Qualify, Who Do I Contact?
Contact study personnel listed either under the general study contact or the location nearest you.
Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email ADEAR.
Where Is This Study Located?
Lead: Zhejiang Hisun Pharmaceutical Co. Ltd.
Source: ClinicalTrials.gov ID: NCT03625401