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This is a multi-center, randomized, double-blind, placebo-controlled, parallel group study of two doses of CT1812 in adults with mild to moderate Alzheimer's Disease to evaluate the safety and tolerability of oral CT1812, administered for 28 days. This trial may include up to 8 qualified investigator sites in Australia.
Screening procedures will occur up to 42 days. Eligible subjects will randomized at the clinic on Day 1 and receive the first dose of study drug. Dosing for 28 days thereafter off-site and a total of 5 clinic visits over the treatment period for safety and lab assessments. Then a 7 day post-treatment completion follow-up visit (Day 35) and End of Study for last safety assessments (Day 49).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Treatment-Low | Active Comparator | 6 subjects randomized to 280 mg (Low) CT1812 |
|
| Active Treatment-High | Active Comparator | 6 subjects randomized to 560 mg (High) CT1812 |
|
| Placebo | Placebo Comparator | 4 subjects randomized to matching placebo of CT1812 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT1812 | Drug | Active study drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and review of Treatment Emergent Adverse Events | Treatment Emergent Adverse Events will be assessed by reviewing: Physical Exams; monitoring of vital signs, ECGs, and clinical and laboratory assessments | Up to 30 days |
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Inclusion Criteria:
Exclusion Criteria:
History of or screening brain MRI scan 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).
Clinical or laboratory findings consistent with:
A current DSM-V diagnosis of active major depression, schizophrenia or bipolar disorder.
Clinically significant, advanced or unstable disease that may interfere with outcome measures, and which may bias the assessment of the clinical or mental status of the patient or put the patient at special risk
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| Name | Affiliation | Role |
|---|---|---|
| Michael Woodward, MD | Austin Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Phillip Morris | Southport | Queensland | Australia | |||
| Austin Health |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33559354 | Derived | Izzo NJ, Yuede CM, LaBarbera KM, Limegrover CS, Rehak C, Yurko R, Waybright L, Look G, Rishton G, Safferstein H, Hamby ME, Williams C, Sadlek K, Edwards HM, Davis CS, Grundman M, Schneider LS, DeKosky ST, Chelsky D, Pike I, Henstridge C, Blennow K, Zetterberg H, LeVine H 3rd, Spires-Jones TL, Cirrito JR, Catalano SM. Preclinical and clinical biomarker studies of CT1812: A novel approach to Alzheimer's disease modification. Alzheimers Dement. 2021 Aug;17(8):1365-1382. doi: 10.1002/alz.12302. Epub 2021 Feb 8. |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D004341 | Drug Evaluation |
| ID | Term |
|---|---|
| D000076722 | Drug Development |
| D008919 | Investigative Techniques |
| D005069 | Evaluation Studies as Topic |
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| Placebo | Drug | non-active study drug |
|
|
| Ivanhoe |
| Victoria |
| 3079 |
| Australia |
| Epworth Hospital | Melbourne | Victoria | 3121 | Australia |
| The Royal Melbourne Hospital Hospital | Parkville | Victoria | 3050 | Australia |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |