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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01592552
Recruitment Status : Completed
First Posted : May 7, 2012
Last Update Posted : April 8, 2019
Sponsor:
Information provided by (Responsible Party):
Sanguine Biosciences

Tracking Information
First Submitted Date November 16, 2011
First Posted Date May 7, 2012
Last Update Posted Date April 8, 2019
Study Start Date November 2011
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 4, 2012)		 Biospecimens & Clinical Data collection from patients with neurological diseases. [ Time Frame: 2 years ]
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Biospecimen and Clinical Data Study on Patients With Alzheimer's, Multiple Sclerosis, Parkinson's, and Huntington's, for Drug & Biomarker Discovery
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
Brief Summary 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.
Detailed Description Blood samples are collected in the comfort and safety of your home by a certified medical professional. We have mobile phlebotomists located in major metropolitan areas around the nation for your convenience.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population A diagnosis of Multiple Sclerosis, Alzheimer's, Huntington's, or Parkinson's Disease.
Condition
  • Alzheimer's Disease
  • Multiple Sclerosis
  • Parkinson's Disease
  • Huntington's Disease
  • Amyotrophic Lateral Sclerosis (ALS)
Intervention Not Provided
Study Groups/Cohorts
  • Neurological Condition
    Collect blood and other biospecimens like saliva, urine and CSF for research purposes.
  • Control
    Collect blood and other biospecimens like saliva, urine and CSF for research purposes.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 1, 2016)		 20
Original Estimated Enrollment
 (submitted: May 4, 2012)		 300
Actual Study Completion Date March 2015
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Males and females >18 to 100 years old
  • A diagnosis of neurological condition
  • Proof of diagnosis can be provided

Control group: Healthy donors, males and females, 18 to 100 years of age

Exclusion Criteria

  • Receipt of blood products within 30 days of study enrollment
  • Receipt of an investigational (unapproved) drug within 30 days of study enrollment
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01592552
Other Study ID Numbers SAN-ND-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Sanguine Biosciences
Original Responsible Party Same as current
Current Study Sponsor Sanguine Biosciences
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Phil Silkoff, MD Sanguine Biosciences
PRS Account Sanguine Biosciences
Verification Date April 2019