Start: October 2, 2018
End: July 2024
What Is This Study About?
This Phase II trial will study the safety and efficacy of two different doses of the research drug CT1812 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 six-month decline in cognitive function
- Non-childbearing potential (postmenopausal or undergone a bilateral tubal ligation or hysterectomy)
- Males who are sexually active with a woman of child-bearing potential must agree to use condoms during the trial and for three months after unless using acceptable birth control
- Evidence of amyloid in positron emission tomography scan or spinal fluid sample previously or during screening
- Magnetic resonance imaging (MRI) obtained during or one year prior to screening consistent with Alzheimer's disease diagnosis
- Mini-Mental State Examination score of 18 to 26
Must NOT have:
- Brain MRI showing significant abnormality, including prior hemorrhage or infarct greater than one cubic centimeter, more than three lacunar infarcts, cerebral contusion, encephalomalacia, aneurysm, vascular malformation, subdural hematoma, hydrocephalus, or space-occupying lesion
- Evidence of other primary degenerative dementia or neurodegenerative condition (e.g., dementia with Lewy bodies, frontotemporal dementia, Huntington's disease, Creutzfeldt-Jakob Disease, Down syndrome, Parkinson's disease, or amyotrophic lateral sclerosis)
- Seizure disorder
- 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 stable antidepressants are allowed)
- Clinically significant, serious, or unstable disease that could interfere with study
If I Qualify, Who Do I Contact?
Contact study personnel listed either under the general study contact or the location nearest you.
Who Is the General Study Contact?
For more information and to enroll, visit the study website.
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: NCT03507790