Amyotrophic Lateral Sclerosis (ALS) Families Project
ConditionALS
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-105
SponsorColumbia University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Known HIV
Known hepatitis B
Known hepatitis C
Trial population
Unaffected individuals who have either a family member with a known ALS/FTD-associated gene mutation or have a strong family history of ALS and FTD.
Trial design
Design model
Family-based
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Time to emergence of symptoms attributable to gene mutations
Emergence of symptoms will defined by the development of any of the following: a) any weakness on neurological examination, b) evidence of nerve loss on electromyography (EMG)-nerve conduction studies, or c) evidence of cognitive impairment on the ECAS or ALS-Cognitive Behavioral Scale (ALS-CBS).
Time frame
Up to 10 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov