A Study to Evaluate the Safety and Efficacy of CT1812 in Subjects With Mild to Moderate Alzheimer's Disease.
NCT ID: NCT03507790
Last Updated: 2025-08-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
153 participants
INTERVENTIONAL
2018-10-10
2024-05-29
Brief Summary
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Detailed Description
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This Phase 2 study is designed to evaluate the safety of two doses of CT1812 administered once daily for 6 months in adults aged 50 to 85 who have been diagnosed with mild to moderate Alzheimer's disease. Randomized participants will receive 100 mg of CT1812, 300 mg of CT1812, or placebo once daily for 182 days. Exploratory endpoints that evaluate the effect of CT1812 on biomarkers are also included.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Active Treatment- CT1812 100 mg
CT1812 at a dose of 100 mg
CT1812
Active Study Drug
Active Treatment- CT1812 300 mg
CT1812 at a dose of 300mg
CT1812
Active Study Drug
Placebo Comparator - Placebo
Placebo
Placebo
Non-active study drug
Interventions
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CT1812
Active Study Drug
Placebo
Non-active study drug
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
i) Non-childbearing potential for women is defined as postmenopausal (last natural menses greater than 24 months) or undergone a documented bilateral tubal ligation or hysterectomy. If last natural menses less than 24 months, a serum FSH value confirming post-menopausal status can be employed.
ii) Male participants who are sexually active with a woman of child-bearing potential must agree to use condoms during the trial and for 3 months after last dose unless the woman is using an acceptable means of birth control. Acceptable forms of birth control include abstinence, birth control pills, or any double combination of: intrauterine device (IUD), male or female condom, diaphragm, sponge, and cervical cap.
2. Diagnostic confirmation by amyloid PET with florbetaben or another approved amyloid PET ligand. Previous amyloid imaging study with a positive result will be accepted. If none is available, then amyloid PET will be conducted during screening. Diagnostic confirmation by a CSF sample collected at the screening visit lumbar puncture in place of amyloid PET will also be acceptable
Exclusion Criteria
1. Screening MRI (or historical MRI, if applicable) of the brain indicative of significant abnormality, including, but not limited to, prior hemorrhage or infarct \>1 cm3, \>3 lacunar infarcts, cerebral contusion, encephalomalacia, aneurysm, vascular malformation, subdural hematoma, hydrocephalus, space-occupying lesion (e.g. abscess or brain tumor such as meningioma). If a small incidental meningioma is observed, the medical monitor may be contacted to discuss eligibility..
2. Clinical or laboratory findings consistent with:
1. Other primary degenerative dementia, (dementia with Lewy bodies, fronto-temporal dementia, Huntington's disease, Creutzfeldt-Jakob Disease, Down syndrome, etc.).
2. Other neurodegenerative condition (Parkinson's disease, amyotrophic lateral sclerosis, etc.).
3. Seizure disorder.
4. Other infectious, metabolic or systemic diseases affecting the central nervous system (syphilis, present hypothyroidism, present vitamin B12 or folate deficiency, other laboratory values etc.).
3. A current DSM-V diagnosis of active major depression, schizophrenia or bipolar disorder. Subjects with depressive symptoms successfully managed by a stable dose of an antidepressant are allowed entry.
4. Clinically significant, advanced or unstable disease that may interfere with outcome evaluations.
50 Years
85 Years
ALL
No
Sponsors
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National Institute on Aging (NIA)
NIH
Cognition Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Anthony Caggiano, MD
Role: STUDY_DIRECTOR
Cognition Therapeutics
Locations
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21st Century Neurology/ Xenoscience Inc.
Phoenix, Arizona, United States
Imaging Endpoints
Scottsdale, Arizona, United States
Ki Health Partners, LLC dba New England Institute for Clinical Research
Stamford, Connecticut, United States
JEM Research Institute
Atlantis, Florida, United States
Charter Research
Lady Lake, Florida, United States
ClinCloud, LLC
Maitland, Florida, United States
Allied Biomedical Research Institute
Miami, Florida, United States
Compass Research LLC- Bioclinica Research
The Villages, Florida, United States
ClinCloud
Viera, Florida, United States
Alzheimer's Memory Center
Charlotte, North Carolina, United States
The Ohio State University - Wexner
Columbus, Ohio, United States
Neuro Behavirol Clinical Research C
North Canton, Ohio, United States
St Vincent's Hospital Sydney
Ivanhoe, Victoria, Australia
Alfred Health
Melbourne, Victoria, Australia
Melbourne Health
Parkville, Victoria, Australia
Australian Alzheimer's Research Foundation
Nedlands, Western Australia, Australia
Neuro Health Centrum ltd
Brno, , Czechia
NeuropsychiatrieHK S.R.O
Hradec Králové, , Czechia
A-Shine S.R.O
Pilsen, , Czechia
Clintrial S.R.O
Prague, , Czechia
Neuropsychiatrie s.r.o.
Prague, , Czechia
Forbeli S.R.O
Prague, , Czechia
INEP
Prague, , Czechia
Vestra Clinics
Rychnov nad Kněžnou, , Czechia
Brain Research Den Bosch
's-Hertogenbosch, , Netherlands
Brain Research Center Amsterdam
Amsterdam, , Netherlands
Brain Research Center Zwolle
Zwolle, , Netherlands
Fundación ACE
Barcelona, , Spain
Hospital Clinico Universitario Virgen De La Arrixaca
El Palmar, , Spain
Centro de Salud San Juan
Salamanca, , Spain
Hospital Victoria EUGENIA. Unidad de Neurociencias.
Seville, , Spain
Fundación Neuropolis - Hospital Viamed Montecanal
Zaragoza, , Spain
Countries
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References
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Lizama BN, North HA, Pandey K, Williams C, Duong D, Cho E, Di Caro V, Ping L, Blennow K, Zetterberg H, Lah J, Levey AI, Grundman M, Caggiano AO, Seyfried NT, Hamby ME. An interim exploratory proteomics biomarker analysis of a phase 2 clinical trial to assess the impact of CT1812 in Alzheimer's disease. Neurobiol Dis. 2024 Sep;199:106575. doi: 10.1016/j.nbd.2024.106575. Epub 2024 Jun 22.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Shine Study Information
Other Identifiers
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2022-002326-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
COG0201
Identifier Type: -
Identifier Source: org_study_id
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