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Clinical Trial of CT1812 in Mild to Moderate Alzheimer's Disease
A Randomized, Double-Blind, Placebo-Controlled, Phase I Study of the Safety & Pharmacokinetics of Two Doses of CT1812 in Subjects With Mild to Moderate Alzheimer's Disease
Lead sponsor
Asset
CT1812
Listed sites
4
Recruiting sites
-
Enrollment
19
actual
Study population
Alzheimer’s disease
Key I/E criteria
•mild-to-moderate AD•MMSE 18-26•Study partner/caregiver required
Primary endpoint
•Incidence and review of Treatment Emergent Adverse Events
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Drug assets
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. Willing and able to provide written informed consent prior to initiation of any study-related procedures. For subjects unable to provide written consent, consent will be provided by the Person Responsible per local regulations.
2. Men and women, 50-80 years in age inclusively with a diagnosis of mild to moderate Alzheimer's disease according to the 2011 NIA-AA. Women must be neither pregnant nor nursing, and are either surgically sterile, postmenopausal or premenopausal using an acceptable method of contraception.
3. Previous decline in cognition for more than six months.
4. Neuroimaging (MRI) obtained within the previous 6 months or during screening, consistent with the clinical diagnosis of Alzheimer's disease.
5. MMSE 18-26 inclusive.
6. No active depression and a Geriatric Depression Score (GDS) of < 6.
7. Modified Hachinski Ischemia score ≤ 4.
8. Formal education of eight or more years.
9. Living at home or in a community setting (assisted living) without continuous nursing care. Each subject must have a reliable caregiver who sees them at least 3 times weekly, can oversee the administration of study drug, and is willing and able to participate in all clinic visits and some study procedures. Responsible caregiver must provide written informed consent to participate.
10. Concurrent use of acetylcholinesterase inhibitors or memantine must be stable for 90 days prior to screening and not expected to change
Exclusion criteria
1. 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).
2. Clinical or laboratory findings consistent with:
1. Other primary degenerative dementia,
2. Other neurodegenerative condition
3. Seizure disorder
4. Other infectious, metabolic or systemic diseases affecting the central nervous system
3. A current DSM-V diagnosis of active major depression, schizophrenia or bipolar disorder.
4. 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
Endpoints (1)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Safety / tolerability / PK
1 endpointIncidence and review of Treatment Emergent Adverse Events
Time frame:Up to 30 days
event count, event
Publications (1)
Bibliography
Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.
Registry references + supporting bibliography
- PMID33559354via DERIVED
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.