Start: August 1, 2019
End: December 1, 2020
What Is This Study About?
This Phase I study will examine the safety of single and multiple doses of NNI-362 in healthy older adults as a potential treatment for Alzheimer's disease. NNI-362 is a being studied for its potential to stimulate neurons in order to stop or slow the cognitive impairment seen with Alzheimer's disease. Participants in this study will be randomly assigned to take a liquid dose of either a placebo or study drug in escalating doses of 10 mg, 20 mg, and 60 mg.
Do I Qualify To Participate in This Study?
- Reasonably good health as determined from medical history, vital signs measurements, physical examination, screening laboratory results, and electrocardiogram
- Well-controlled, chronic, and stable medical conditions (e.g., high blood pressure, osteoarthritis, noninsulin dependent diabetes, osteoporosis, gout, Paget's disease, hypothyroidism) will not be exclusionary if not expected to interfere with participant safety or the study
- Negative urine screen for drugs of abuse within 24 hours study drug doses
- Body mass index of 18 to 30 and total body weight greater than 106 pounds
Must NOT have:
- Women of childbearing potential
- Pregnant or breastfeeding
- Significant laboratory test result, including abnormal liver enzyme, serum creatinine, hemoglobin, white blood cell, or platelet levels
- Significant medical illness, including chronic obstructive pulmonary disease, sleep apnea, heart arrhythmia, congestive heart failure, valvular or ischemic heart disease, pulmonary high blood pressure, kidney or urinary tract disorder, active peptic ulcer disease, gastrointestinal bleeding, inflammatory bowel disease, chronic pancreatitis, liver disease (excluding Gilbert's syndrome), and any neurologic disorder other than chronic Bell's palsy
- History of malignancy that has not been cured or in complete remission for at least 10 years (excluding resected nonmetastatic basal cell carcinoma)
- History of seizure activity other than early childhood
- Any traumatic brain injury in adulthood
- Current smoker or nicotine user or quit within past 2 months
- Active substance abuse
- Glomerular filtration rate (a measure of kidney performance) less than 50 mL/min based on Cockcroft-Gault calculation
- Difficulty swallowing
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: Neuronascent, Inc.
National Institute on Aging (NIA)
Source: ClinicalTrials.gov ID: NCT04074837