A Biospecimen and Clinical Data Study on Patients With Alzheimer's, Multiple Sclerosis, Parkinson's, and Huntington's, for Drug & Biomarker Discovery

This study is currently recruiting participants.
Verified December 2013 by Sanguine Biosciences
Sponsor:
Information provided by (Responsible Party):
Sanguine Biosciences
ClinicalTrials.gov Identifier:
NCT01592552
First received: November 16, 2011
Last updated: December 11, 2013
Last verified: December 2013
  Purpose

The purpose of this research project is to collect and store blood samples and clinical data. Researchers can then use the stored samples in future studies. Through such studies, they hope to find new ways to detect, treat, and maybe even prevent or cure health problems.


Condition Intervention
Alzheimer's Disease
Multiple Sclerosis
Parkinson's Disease
Huntington's Disease
Other: blood samples

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: A Multi-Center Longitudinal Biorepository Study to Provide Biospecimens & Clinical Data From Neurological Disease Patients To Approved Pre-Clinical And Clinical Investigators for Drug & Biomarker Studies

Resource links provided by NLM:


Further study details as provided by Sanguine Biosciences:

Primary Outcome Measures:
  • Biospecimens & Clinical Data collection from patients with neurological diseases. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    The purpose of this research project is to collect and store blood samples and clinical data. Researchers can then use the stored samples in future studies. Through such studies, they hope to find new ways to detect, treat, and maybe even prevent or cure health problems.


Estimated Enrollment: 300
Study Start Date: November 2011
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

A diagnosis of Multiple Sclerosis, Alzheimer's, Huntington's, or Parkinson's Disease.

Criteria

Inclusion Criteria:

  • Males and females >18 to 80 years of age at blood draw date.
  • A diagnosis of Multiple Sclerosis, Alzheimer's, Huntington's, or Parkinson's Disease made at any time prior to blood draw. Blood draw and diagnosis at same visit is adequate.
  • The date of diagnosis of MS, Alzheimer's, Huntington's, or Parkinson's Disease is known (this date may be from the medical records or may be self-reported by the patient with approval from the Sponsor).
  • The diagnosis is confirmable in the medical record by any of the following criteria: clinical information, MRI scan (evidence of 2 or more lesions), and Lumbar Puncture.
  • Control group: Healthy donors, males and females, 18 to 80 years of age
  • Patient and control group: Subject medical records are available
  • Patient and control group: Understands the procedures and requirements of the study by providing written informed consent including consent for authorization for protected health information disclosure.

Exclusion Criteria

  • Receipt of blood products prior to study entry.
  • Known pregnancy or having given birth within the past 3 months.
  • Receipt of an investigational (unapproved) drug 30 days prior to the blood draw.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01592552

Contacts
Contact: Carlyn Crisostomo 877-864-3053 donors@sanguinebio.com
Contact: Kendra Hughes, MA 877-864-3053 donors@sanguinebio.com

Locations
United States, California
Sanguine Biosciences Recruiting
Valencia, California, United States, 91355
Contact: Carlyn Crisostomo    877-864-3053    donors@sanguinebio.com   
Principal Investigator: Carlyn Crisostomo         
Sponsors and Collaborators
Sanguine Biosciences
Investigators
Principal Investigator: Carlyn Crisostomo Sanguine Biosciences
  More Information

No publications provided

Responsible Party: Sanguine Biosciences
ClinicalTrials.gov Identifier: NCT01592552     History of Changes
Other Study ID Numbers: SAN-ND-01
Study First Received: November 16, 2011
Last Updated: December 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Sanguine Biosciences:
Alzheimer's Disease
Multiple Sclerosis
Parkinson's Disease
Huntington's Disease

Additional relevant MeSH terms:
Chorea
Alzheimer Disease
Huntington Disease
Multiple Sclerosis
Parkinson Disease
Sclerosis
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Basal Ganglia Diseases
Dyskinesias
Movement Disorders
Heredodegenerative Disorders, Nervous System
Genetic Diseases, Inborn
Cognition Disorders
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Parkinsonian Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on April 20, 2014