Clinical Trial on ALS (Amyotrophic Lateral Sclerosis), Alzheimer's Disease (AD), Parkinson's Disease (PD), Frontotemporal Degeneration (FTD), Dementia With Lewy Bodies (DLB), Parkinson's Disease Dementia (PDD) - Clinical Trials Registry

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Cara Joyce, MPH
Phone Number: 267-271-0740
Email: cara.joyce@pennmedicine.upenn.edu

Study Contact Backup

Name: Emily Xie
Phone Number: 16109553114
Email: emily.xie@pennmedicine.upenn.edu

Study Locations

United States
- Pennsylvania
  - Philadelphia, Pennsylvania, United States, 19104
    - Recruiting
    - University of Pennsylvania
    - Principal Investigator:
      
      Corey McMillan, PhD
    - Contact:
      
      Cara Joyce, MPH
      
      Phone Number: 267-271-0740
      
      Email: cara.joyce@pennmedicine.upenn.edu
    - Contact:
      
      Emily Xie
      
      Email: emily.xie@pennmedicine.upenn.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

This study will recruit adults over the age of 18 who fit into one of the three study groups defined in the eligibility criteria above.

Description

Inclusion Criteria:

People with a clinical diagnosis of a neurodegenerative disease including, but not limited to Alzheimer's disease (AD), Parkinson's disease (PD), Parkinson's disease dementia (PDD), dementia with Lewy bodies (DLB), frontotemporal dementia (FTD), amyotrophic lateral sclerosis (ALS), progressive supranuclear palsy (PSP), primary progressive aphasia (PPA), limbic-predominant age-related TDP-43 encephalopathy (LATE), corticobasal syndrome (CBS), posterior cortical atrophy (PCA), primary lateral sclerosis (PLS), primary muscular atrophy (PMA), or individuals with a suspected neurodegenerative dementia and/or movement disorder of unknown etiology will be considered for enrollment
Family Members of individuals who meet the criteria of group 1, who are people who may or may not be at risk for a similar neurodegenerative disease, who may or may not be symptomatic, and who may or may not have known or unknown genetic risk.
People with no known neurological disease who will provide control data.

Exclusion Criteria:

Anyone who is under the age of 18.
Anyone with a condition or in a situation which, in the investigator's opinion, could confound the study findings or may interfere significantly with a person's participation, including but not limited to neurological, psychological, and other medical conditions (such as cardiac, neurosurgical, infectious conditions).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
People with a clinical diagnosis of neurodegenerative disease People with a clinical diagnosis of a neurodegenerative disease including, but not limited to Alzheimer's disease (AD), Parkinson's disease (PD), Parkinson's disease dementia (PDD), dementia with Lewy bodies (DLB), frontotemporal dementia (FTD), amyotrophic lateral sclerosis (ALS), progressive supranuclear palsy (PSP), primary progressive aphasia (PPA), limbic-predominant age-related TDP-43 encephalopathy (LATE), corticobasal syndrome (CBS), posterior cortical atrophy (PCA), primary lateral sclerosis (PLS), primary muscular atrophy (PMA), or individuals with a suspected neurodegenerative dementia and/or movement disorder of unknown etiology will be considered for enrollment.
Family members of individuals meeting criteria for group 1 Family Members of individuals who meet the criteria of group 1, who are people who may or may not be at risk for a similar neurodegenerative disease, who may or may not be symptomatic, and who may or may not have known or unknown genetic risk.
Healthy Controls People with no known neurological disease who will provide control data.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To contribute to and continue to sustain a repository biological samples and data from individuals with age-related neurodegenerative conditions. Time Frame: This is a natural history study-participants are followed from date of enrollment until death, withdraw, or funding is no longer available, or until 600 months have passed.	To contribute to and continue to sustain a repository of blood samples, nucleic acid (DNA and/or RNA) samples, family history information, and other demographic information from individuals with age-related neurodegenerative conditions.	This is a natural history study-participants are followed from date of enrollment until death, withdraw, or funding is no longer available, or until 600 months have passed.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To collect and bank data and biospecimen samples Time Frame: This is a natural history study-participants are followed from date of enrollment until death, withdraw, or funding is no longer available, or until 600 months have passed.	To collect and bank data and biospecimen samples locally and at collaborating data and biobank repositories in support of neurodegenerative disease research. Data and biospecimen samples may be collected as part of an external protocol (e.g., a different Penn IRB-approved observational protocol, clinical trial, or consortium study) in which participants may be co-enrolled	This is a natural history study-participants are followed from date of enrollment until death, withdraw, or funding is no longer available, or until 600 months have passed.
To collect data and biospecimen samples from people who wish to participate in research but are unable to participate or do not meet eligibility criteria for other research protocols at our lab. Time Frame: This is a natural history study-participants are followed from date of enrollment until death, withdraw, or funding is no longer available, or until 600 months have passed.	To collect data and biospecimen samples from people who wish to participate in research but are unable to participate or do not meet eligibility criteria for other research protocols at our lab, e.g., a carrier of a rare genetic variant associated with a neurodegenerative disease.	This is a natural history study-participants are followed from date of enrollment until death, withdraw, or funding is no longer available, or until 600 months have passed.
To extend analysis, maintenance, and sharing of existing data. Time Frame: This is a natural history study-participants are followed from date of enrollment until death, withdraw, or funding is no longer available, or until 600 months have passed.	To extend analysis, maintenance, and sharing of existing data, imaging, and biospecimen samples collected by our lab under previous research protocols	This is a natural history study-participants are followed from date of enrollment until death, withdraw, or funding is no longer available, or until 600 months have passed.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Collaborators

National Institute of Neurological Disorders and Stroke (NINDS)

National Institute on Aging (NIA)

University of Pennsylvania Institute on Aging

Investigators

Principal Investigator: Corey McMillan, PhD, University of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

None to list.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 12, 2025

Primary Completion (Estimated)

January 1, 2070

Study Completion (Estimated)

January 1, 2070

Study Registration Dates

First Submitted

August 19, 2026

First Submitted That Met QC Criteria

August 28, 2026

First Posted (Actual)

September 1, 2026

Study Record Updates

Last Update Posted (Actual)