Start: April 20, 2018
End: October 2020
What Is This Study About?
This Phase I/II study will test the effects of the investigational drug CT1812 on brain synaptic density in adults with mild to moderate Alzheimer's disease.
Do I Qualify To Participate in This Study?
- Diagnosis of mild to moderate Alzheimer's disease and at least a 6-month decline in cognitive function documented in medical record
- Women must be postmenopausal or have undergone a bilateral tubal ligation or hysterectomy
- Men who are sexually active with a woman of childbearing potential must agree to use condoms during the trial and for 3 months after last dose unless the woman is using birth control
- Magnetic resonance imaging (MRI) consistent with diagnosis of Alzheimer's disease and without findings of significant exclusionary abnormalities
- Mini-Mental State Examination score of 18 to 26
- Positive amyloid positron emission tomography (PET) scan at screening, history of a positive amyloid scan, or prior lumbar puncture with an amyloid-beta concentration consistent with Alzheimer's disease
- Formal education of 8 or more years
- Caregiver who sees participant at least 10 hours per week, and can oversee administration of study drug and participate in study visits and assessments
- Living at home or in the community (assisted living acceptable)
- Drug treatment of any chronic conditions must be stable for at least 30 days
- Consent to APOE genotyping
- Generally healthy with vision, hearing, and mobility sufficient to complete testing (hearing aids and walkers/canes permissible)
Must NOT have:
- Hospitalization or change of chronic medication within past month
- Living in a continuous care nursing facility
- Brain MRI showing significant abnormality, including prior hemorrhage or infarct greater than 1 cubic centimeter, more than 3 lacunar infarcts, cerebral contusion, encephalomalacia, aneurysm, vascular malformation, subdural hematoma, hydrocephalus, or space-occupying lesion
- MRI-incompatible implants and other contraindications for MRI, such as pacemaker, artificial joints, non-removable body piercings, and claustrophobia
- Participation in other research studies involving ionizing radiation that would cause the participant to exceed yearly dose limits
- History of IV drug use that would prevent venous access for PET tracer injection
- Conditions such as severe motor problems or chronic pain that would prevent participant from lying still for brain imaging
- Evidence of seizure disorder or other neurodegenerative condition (e.g., Lewy body dementia, frontotemporal dementia, Huntington's disease, Creutzfeldt-Jakob Disease, Parkinson's disease, or amyotrophic lateral sclerosis)
- Other infectious, metabolic, or systemic diseases affecting the central nervous system (e.g., syphilis, hypothyroidism, or vitamin B12 or folate deficiency)
- Diagnosis of active major depression, schizophrenia, or bipolar disorder (depressive symptoms managed by a stable dose of antidepressant are allowed)
- Clinically significant, advanced, or unstable disease, including chronic liver disease, hepatic insufficiency, respiratory insufficiency, renal insufficiency, heart disease (heart attack, unstable angina, heart failure, cardiomyopathy within past 6 months), and bradycardia or tachycardia (abnormally slow or rapid heart rate)
- Poorly managed low or high blood pressure (systolic less than 90 or greater than 160 and/or diastolic less than 60 or greater than 95)
- Uncontrolled diabetes
- Cancer within past 3 years, except fully excised non-melanoma skin cancers or non-metastatic prostate cancer that has been stable for at least 6 months
- Seropositive for HIV
- History of acute/chronic hepatitis B or C and/or carrier of hepatitis B
- Clinically significant abnormalities in screening laboratory tests
- Small bowel disease, Crohn's disease, celiac disease, liver disease, or any disorder that could interfere with the absorption, distribution, metabolism, or excretion of drugs
- Prohibited medications: Nootropic drugs other than stable Alzheimer's disease medications, antipsychotic agents (except certain doses of risperidone, quetiapine, olanzapine, and aripiprazole), antiepileptics (except gabapentin and pregabalin for nonseizure indications), centrally active antihypertensive drugs, opiate analgesics, systemic corticosteroids, psychostimulants, antiparkinsonian medications (except for non-parkinsonian indications), mood stabilizers, sedatives and anti-anxiety agents
- Use of sedatives or hypnotics should be avoided for 8 hours before cognitive tests
- Drug or alcohol abuse
- Allergy to any components of the study treatments
- Enrollment in another investigational study or intake of investigational drug within the past 30 days or five half-lives, whichever is longer
- Previous exposure to anti-amyloid-beta vaccines
- Exposure to passive immunotherapies for Alzheimer's disease (e.g. monoclonal antibodies) or BACE inhibitors within past 180 days
- Inability to undergo a lumbar puncture, including infection at the desired lumbar puncture site, use of anti-coagulant medication within past 90 days (low-dose aspirin is permitted), degenerative arthritis of the lumbar spine, suspected non-communicating hydrocephalus or intracranial mass, or prior history of spinal mass or trauma
- Use of nonsteroidal anti-inflammatory drugs for more than 2 days in any 7-day period
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: Cognition Therapeutics
Source: ClinicalTrials.gov ID: NCT03493282