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 May 2012 by Sanguine Biosciences
Sponsor:
Sanguine Biosciences
Information provided by (Responsible Party):
Sanguine Biosciences
ClinicalTrials.gov Identifier:
NCT01592552
First received: November 16, 2011
Last updated: May 8, 2012
Last verified: May 2012
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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:
Genetics Home Reference related topics:
Alzheimer disease
chorea-acanthocytosis
Huntington disease
McLeod neuroacanthocytosis syndrome
multiple sclerosis
Parkinson disease
Perry syndrome
MedlinePlus related topics:
Alzheimer's Disease
Huntington's Disease
Multiple Sclerosis
Neurologic Diseases
Parkinson's Disease
U.S. FDA Resources
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 2013 |
| Estimated Primary Completion Date: | October 2013 (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: Sascha Hasan, PhD, MBA | 310.403.5669 | sascha@sanguinebio.com |
| Contact: Carlyn Crisostomo | 1.866.619.1301 | carlyn@sanguinebio.com |
Locations
| United States, California | |
| Sanguine Biosciences | Recruiting |
| Valencia, California, United States, 91355 | |
| Contact: Sascha Hasan, PhD, MBA 310-403-5669 sascha@sanguinebio.com | |
| Principal Investigator: Sascha Hasan, PhD, MBA | |
| Sub-Investigator: Carlyn Crisostomo | |
Sponsors and Collaborators
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: | May 8, 2012 |
| 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:
|
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 |
Chorea 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 June 18, 2013