# Human AME study of CT1812, a small molecule in phase 2 clinical trials for the treatment of Alzheimer's disease

> **NIH NIH SB1** · COGNITION THERAPEUTICS, INC. · 2021 · $1,642,783

## Abstract

PROJECT SUMMARY/ABSTRACT
Alzheimer's disease (AD) afflicts nearly six million people in the United States (U.S), and this number is
expected to double by 2050. Disease modifying medical therapies for AD continue to be an unmet need. The
symptomatic treatments currently available regulate neurotransmitter levels, slowing cognitive decline for an
average of only 6 months.
Cognition Therapeutics (CogRx) is developing CT1812, the first brain penetrant small molecule that selectively
clears toxic beta amyloid oligomers (AβOs) from the brain into cerebrospinal fluid (CSF). CT1812's mechanism
of action has the potential to halt or slow cognitive decline, significantly alleviating AD progression.
CT1812 is currently in Phase 2 trials in patients. Before CogRx can proceed to larger and longer studies that
evaluate efficacy, a human Absorption, Metabolism, and Excretion (AME) study must be conducted per Food
and Drug Administration expectations, to establish a robust and comprehensive knowledge of CT1812's
pharmacokinetics (PK) and key metabolites.
Approach. The overall research design will include (Aim 1) purifying and characterizing radiolabeled CT1812
in sufficient quantities with sufficient quality; (Aim 2) conducting an open-label AME clinical trial in which up to
six healthy male volunteers are given oral [14C]-CT1812, followed by plasma, urine and feces collection for up
to 14 days, and (Aim 3) analyzing samples to determine mass balance recovery, PK, and identification and
quantification of the relative abundances of the metabolites.
CogRx's long-term objective is to develop CT1812 as a potential disease-modifying therapeutic for AD
treatment. Because no AD disease-modifying therapies exist currently, CT1812 would significantly advance AD
treatment armamentarium.
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## Key facts

- **NIH application ID:** 10247968
- **Project number:** 1SB1AG073028-01A1
- **Recipient organization:** COGNITION THERAPEUTICS, INC.
- **Principal Investigator:** ANTHONY O CAGGIANO
- **Activity code:** SB1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $1,642,783
- **Award type:** 1
- **Project period:** 2021-05-01 → 2023-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10247968

## Citation

> US National Institutes of Health, RePORTER application 10247968, Human AME study of CT1812, a small molecule in phase 2 clinical trials for the treatment of Alzheimer's disease (1SB1AG073028-01A1). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10247968. Licensed CC0.

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