# Clinical Research in ALS and Related Disorders for Therapeutic Development (CReATe)

> **NIH NIH U54** · UNIVERSITY OF MIAMI SCHOOL OF MEDICINE · 2021 · $1,555,588

## Abstract

Project Summary / Abstract
The Clinical Research in ALS and related disorders for Therapy Development (CReATe) Consortium is a Rare
Diseases Clinical Research Consortium (RDCRC) that forms part of the National Institutes of Health Rare
Diseases Clinical Research Network (RDCRN). CReATe comprises a multi-disciplinary group of clinicians,
scientists, educators, patient advocacy groups and other strategic partners, and aims to advance therapeutic
development for patients with amyotrophic lateral sclerosis (ALS) and related disorders including progressive
muscular atrophy (PMA), primary lateral sclerosis (PLS), frontotemporal dementia (FTD), multisystem
proteinopathy (MSP), and hereditary spastic paraplegia (HSP). We recognize that the obstacles to therapeutic
development are multifactorial and include: (a) etiological and biological heterogeneity; (b) phenotypic
heterogeneity; (c) limitations of existing clinical outcome measures for use in early-to-mid phase clinical trials;
(d) a paucity of biomarkers that have been validated as “fit for purpose”); (e) the relatively late stage at which
symptoms appear, diagnosis is made, and treatment is initiated; and (f) variable (often low) rates of patient
participation in clinical research studies. CReATe investigators are engaged in a range of clinical trial
readiness activities that aim to overcome these obstacles, and to thereby advance therapeutic development for
this group of rare diseases. In addition, CReATe aims to promote and support collaborative research in the
field of ALS and related disorders; develop and disseminate resources such as the CReATe Biorepository and
our electronic health record-based ALS Toolkit that are of value to the broader scientific community; lower
barriers to patient participation in research; cultivate and enhance the careers of young clinical investigators
and translational scientists dedicated to the study of this group of rare diseases; and engage both lay- and
scientific-community stakeholders in a partnership that fosters efforts to develop treatments for patients
afflicted with these rare diseases.

## Key facts

- **NIH application ID:** 10242880
- **Project number:** 5U54NS092091-08
- **Recipient organization:** UNIVERSITY OF MIAMI SCHOOL OF MEDICINE
- **Principal Investigator:** Michael Benatar
- **Activity code:** U54 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $1,555,588
- **Award type:** 5
- **Project period:** 2014-09-30 → 2024-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10242880

## Citation

> US National Institutes of Health, RePORTER application 10242880, Clinical Research in ALS and Related Disorders for Therapeutic Development (CReATe) (5U54NS092091-08). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10242880. Licensed CC0.

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