What this study is
This program provides family members of individuals with familial ALS the opportunity to contribute to research focused on learning more about why motor neuron degeneration begins and how or why it progresses. This study provides genetic counseling and testing to help participants understand and manage their risk and determine if they want to learn their genetic status. This study will follow unaffected ALS gene mutation carriers on an annual basis to gather essential information that will ultimately help researchers develop novel therapies for the prevention and treatment of ALS.
Study details
- Sponsor
- Columbia University
- Conditions
- ALS
- Enrolling
- 300 people
- Starts
- 2018-09-11
- Est. completion
- 2027-01
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 105 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- Men or women of any race or ethnicity aged 18 or older
- No symptoms of ALS or fronto-temporal dementia at enrollment
- Scenario 1: has already had genetic testing that identified an ALS-spectrum gene mutation.
- Scenario 2: has a first degree relative who was/is an obligate carrier of a familial ALS-spectrum gene mutation.
- Scenario 3: has a first degree relative who has/had an ALS-spectrum diagnosis who had a confirmed ALS-spectrum gene mutation or comes from a family with a high burden of ALS-spectrum diagnoses and a known ALS-spectrum gene mutation.
- Scenario 4: is deemed to be at high risk for carrying an ALS-spectrum gene mutation as judged by a review of the family structure and genetic information by the study team.
- Willing to undergo genetic analysis, with option of whether or not to learn results
- Willing to travel to Columbia University Irving Medical Center (CUIMC) every 6-24 months for study procedures
- Capable of providing informed consent and following study procedures, or has a legally authorized representative who is able to consent for the subject. Exclusion Criteria for participation in biosample portion of the study:; Known HIV; Known hepatitis B; Known hepatitis C
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
Study locations (1)
1 openColumbia University
New York, New York, United States
- Elizabeth Harrington, MS, CGC · Contact347-852-5315ALSFamiliesProject@cumc.columbia.edu
Recruiting
Study team
Sponsor
Columbia University
Study ID AAAR7275
Principal investigator
Matthew Harms, MD
Columbia University
CONTACT
Matthew Harms, MD
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.