Alzheimer's DiseaseNCT01592552
A Biospecimen and Clinical Data Study on Patients for Drug & Biomarker Discovery
An observational study of Alzheimer's Disease and Multiple Sclerosis, run by Sanguine Biosciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease, Multiple Sclerosis, Parkinson's Disease
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Mar 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A diagnosis of Multiple Sclerosis, Alzheimer's, Huntington's, or Parkinson's Disease.
Who may be able to join
- 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
Who cannot join
- Receipt of blood products within 30 days of study enrollment
- Receipt of an investigational (unapproved) drug within 30 days of study enrollment
Trial locations and contacts
1 site in 1 country.
United States1 site
Sanguine Biosciences
Sherman Oaks, California, 91403
About this study
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
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.
Read the 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.
- Conditions
- Alzheimer's Disease, Multiple Sclerosis, Parkinson's Disease, Huntington's Disease, Amyotrophic Lateral Sclerosis (ALS)
- Keywords
- Alzheimer's Disease, Multiple Sclerosis, Parkinson's Disease, Huntington's Disease, Amyotrophic Lateral Sclerosis (ALS)
- Medical subject headings
- Alzheimer Disease, Multiple Sclerosis, Parkinson Disease, Huntington Disease, Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biospecimens & Clinical Data collection from patients with neurological diseases.
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2012 (estimated)
- Study startNov 2011
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanguine Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Phil Silkoff, MD, Principal investigator, Sanguine Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01592552
- Sponsor's protocol ID
- SAN-ND-01
- Status last verified
- Nov 2023
- First submitted
- 16 Nov 2011
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01592552
- Acronym / sponsor ID
- SAN-ND-01
- Conditions
- Alzheimer's Disease, Multiple Sclerosis, Parkinson's Disease, Huntington's Disease, Amyotrophic Lateral Sclerosis (ALS)
- Keywords
- Alzheimer's Disease, Multiple Sclerosis, Parkinson's Disease, Huntington's Disease, Amyotrophic Lateral Sclerosis (ALS)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Sanguine BiosciencesIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 7 May 2012 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A diagnosis of Multiple Sclerosis, Alzheimer's, Huntington's, or Parkinson's Disease.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Receipt of blood products within 30 days of study enrollment
- Receipt of an investigational (unapproved) drug within 30 days of study enrollment
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
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.
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 22 Nov 2023.
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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.
Phil Silkoff, MD principal investigator
Sanguine Biosciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer's Disease and Multiple Sclerosis, run by Sanguine Biosciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biospecimens & Clinical Data collection from patients with neurological diseases. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023.