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Trial record 3 of 11 for:    progenabiome

A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Alzheimer's Disease

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ClinicalTrials.gov Identifier: NCT04100889
Recruitment Status : Not yet recruiting
First Posted : September 24, 2019
Last Update Posted : September 24, 2019
Sponsor:
Information provided by (Responsible Party):
ProgenaBiome

Brief Summary:
This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding Alzheimer's disease.

Condition or disease Intervention/treatment
Alzheimer Disease Alzheimer Disease 1 Alzheimer Disease 2 Alzheimer Disease 3 Alzheimer Disease 4 Alzheimer Disease 5 Alzheimer Disease 6 Alzheimer Disease 7 Alzheimer Disease 8 Alzheimer Disease 9, Late-Onset Alzheimer Disease 10 Alzheimer Disease 11 Alzheimer Disease 12 Alzheimer Disease 13 Alzheimer Disease 14 Alzheimer Disease 15 Alzheimer Disease 16 Alzheimer Disease 17 Alzheimer Disease 18 Alzheimer Disease 19 Alzheimer Disease, Early Onset Alzheimer Disease, Late Onset Alzheimer Disease Focal Other: No Intervention

Detailed Description:
The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to the information provided in surveys and in medical records regarding Alzheimer's disease.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Alzheimer's Disease
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : December 2020


Group/Cohort Intervention/treatment
Alzheimer's disease patients
Patients who have been diagnosed with Alzheimer's disease
Other: No Intervention
There is no intervention for this study.




Primary Outcome Measures :
  1. Correlation of Microbiome to Alzheimer's Disease via Relative Abundance Found in Microbiome Sequencing [ Time Frame: 1 year ]
    Relative abundance of bacterial classes within taxonomic phyla and, more broadly, within their domain will be analyzed by sequencing the gut microbiome. These data will then be correlated to Alzheimer's disease state


Biospecimen Retention:   Samples With DNA
Stool samples


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Patients who are 18 years of age or older and have been diagnosed with Alzheimer's disease.
Criteria

Inclusion Criteria:

  1. Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study
  2. Male or female patients age 18 and older
  3. Diagnosis of Alzheimer's disease or dementia by a physician
  4. Mini Mental Status Exam score less than 26

Exclusion Criteria:

  1. Refusal to sign informed consent form
  2. Treatment with antibiotics within 2 weeks prior to screening
  3. Treatment with probiotics within 2 weeks prior to screening
  4. History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.
  5. Postoperative stoma, ostomy, or ileoanal pouch
  6. Participation in any experimental drug protocol within the past 12 weeks
  7. Treatment with total parenteral nutrition
  8. Any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial
  9. Inability to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04100889


Contacts
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Contact: Sabine Hazan, MD 8053390549 sabinehazan@aim.com
Contact: Jordan Daniels, MS 8053390549 msjordandaniels@gmail.com

Locations
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United States, California
ProgenaBiome
Ventura, California, United States, 93003
Sponsors and Collaborators
ProgenaBiome
Investigators
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Principal Investigator: Sabine Hazan, MS ProgenaBiome

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Responsible Party: ProgenaBiome
ClinicalTrials.gov Identifier: NCT04100889     History of Changes
Other Study ID Numbers: ProgenaBiome-007
First Posted: September 24, 2019    Key Record Dates
Last Update Posted: September 24, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Only aggregated and deidentified data will be shared with other researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ProgenaBiome:
Microbiome
Additional relevant MeSH terms:
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Alzheimer Disease
Late Onset Disorders
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Disease Attributes
Pathologic Processes