# Phase 1 Clinical Trial of CMS121, a Novel Therapeutic Candidate for Alzheimer's Disease

> **NIH NIH R01** · VIROGENICS, INC. · 2022 · $251,666

## Abstract

Abstract
This application requests supplemental funds for the funded grant, 1 R01 AG074447-01, which supports a
first-in-human clinical trial of CMS121, a drug candidate for treatment of Alzheimer's Disease. Since the date
of submission of the application for the parent grant, modifications have become necessary. Two of the
modifications optimize the information obtained from the trial and the third provides an NIA-mandated Data
and Safety Monitoring Board (DSMB). These modifications were unanticipated at the time of submission of
the parent grant application.
Celerion's clinical trial budget has been amended primarily to address the additional costs associated with
shifting the elderly cohort from the single ascending dose (SAD) protocol to the multiple ascending dose
(MAD) protocol, a change that provides multiple advantages. Celerion's separate budget for methods
development now includes additional costs due to the necessity for an additional protocol to provide accurate
measurements of CMS121 and three CMS metabolites in plasma and urine. Another unanticipated increase
in costs results from the NIA requirement that a DSMB be established for all clinical trials funded by NIA,
including Phase I trials.
The major enhancement in the trial design and the necessary improvement in the measurements CMS121
and CMS121 metabolites in plasma and urine will provide valuable data that would otherwise be missed.
Furthermore, these data will be directly relevant for the design of the next phase clinical trial for CMS121.
The NIA-required DSMB will provide NIA staff additional oversight of the trial's progress.

## Key facts

- **NIH application ID:** 10553057
- **Project number:** 3R01AG074447-01S2
- **Recipient organization:** VIROGENICS, INC.
- **Principal Investigator:** Pamela Anne Maher
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $251,666
- **Award type:** 3
- **Project period:** 2021-09-15 → 2023-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10553057

## Citation

> US National Institutes of Health, RePORTER application 10553057, Phase 1 Clinical Trial of CMS121, a Novel Therapeutic Candidate for Alzheimer's Disease (3R01AG074447-01S2). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10553057. Licensed CC0.

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