A Longitudinal Study of Amyotrophic Lateral Sclerosis (ALS) Biomarkers

Study at a glance

From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

A Multicenter Study for the Discovery and Validation of ALS Biomarkers

ClinicalTrials.gov ID

NCT01495390

Acronym / sponsor ID

BIO-ALS-02

Conditions

Amyotrophic Lateral Sclerosis, Nervous System Diseases, Sclerosis, Motor Neuron Disease, Spinal Cord Diseases, Central Nervous System Diseases

Keywords

Biomarkers, Biological Markers, Surrogate Markers, Clinical Markers, Plasma, Cerebrospinal Fluid, DNA, Serum

Study type

Observational

Recruitment status

Completed

Enrolment

139 participants (actual)

Lead sponsor

Massachusetts General HospitalUniversity, hospital or other

Collaborators

ALS Association, ALS Finding a Cure

Study start

Nov 2011

Primary completion

31 Dec 2016 (actual)

Study completion

31 Dec 2016 (actual)

First posted

20 Dec 2011 (estimated)

Results

Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model

Case only

Time perspective

Prospective

Who may qualify

Ages

18 years and older

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

Study population

Volunteers will be invited to participate in this study by their neurologists either in clinic or at a regular scheduled appointment visit

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

1. ALS Functional Rating Scale

   Time frame: Approximately every 4 months

   The ALSFRS-R is a quickly administered (5 min) ordinal rating scale used to determine a subject's assessment of their capability and independence in 12 functional activities. There are 12 questions, graded by the subject 0-4 (4 is normal). Score of 0 (worst) to 48 (best). Reflects speech and swallowing, fine motor skills, large motor skills, and breathing.

2. Vital Capacity (VC)

   Time frame: Approximately every 4 months

   The vital capacity (VC) (percent of predicted normal) was determined using the slow VC method. Vital Capacity is the maximum amount of air a person can expel from the lungs after a maximum inhalation. A subject's VC depends on their age, sex and height. The value is recorded as a percent of predicted normal.

3. Hand Held Dynamometry (HHD)

   Time frame: Approximately every 4 months

   Hand Held Dynamometry (HHD) will be used as a quantitative measure of muscle strength for this study. Six proximal muscle groups will be examined bilaterally in both upper and lower extremities (shoulder flexion, elbow flexion, elbow extension, hip flexion, knee flexion, and knee extension), all of which have been validated against maximum voluntary isometric contraction (MVIC) testing.

4. Ashworth Spasticity Scale

   Time frame: Approximately every 4 months

   This is a standard measure for spasticity, has been used in a previous ALS clinical trials, and is applied in the current trial to evaluate the progression of spasticity due to upper motor neuron dysfunction in ALS.

5. Fronto-Temporal Dementia (FTD) Assessment

   Time frame: Approximately every 4 months

   The FTD Screening Assessment is a quickly administered scale used to evaluate memory, executive functions, and language. It is aimed at determining the presence of subtle dysfunction of these domains of cognition and behavior that may portend the onset of FTD or FTD-like symptoms.

6. ALS Cognitive Behavioral Screen (ALS CBS)

   Time frame: Approximately every 4 months

   The ALS Cognitive Behavioral Screen (ALS-CBS™) is a short measure of cognition and behavior in patients with Amyotrophic Lateral Sclerosis (ALS). The cognitive section includes commonly used elements of standard testing batteries, consisting of 8 tasks, with a possible total score of 20. It can be administered by a physician or other clinical care staff and takes approximately 5 minutes to complete. The behavioral section (ALS Caregiver Behavioral Questionnaire) is composed of questions sensitive to organic brain changes. It consists of a set of questions that compare changes in personality and behavior since the onset of ALS, as well as yes/no questions about mood, pseudobulbar affect, and fatigue. It is completed by a caregiver, family member or other informant during the same time that the patient completes the cognitive portion. The questionnaire typically takes about 2 minutes to complete.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
• Northeast ALS Consortium WebsiteLink provided by the sponsor.
• Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

6 sites in 1 country: see every site and its status.