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

• Conditions: Alzheimer Disease 1; Alzheimer Disease 5; Alzheimer Disease 6; Alzheimer Disease 8; Alzheimer Disease 14; Alzheimer Disease, Late Onset; Alzheimer Disease 2; Alzheimer Disease 7; Alzheimer Disease 9, Late-Onset; Alzheimer Disease 19
• Interventions: Other: No Intervention

• Registration Number: NCT04100889
• Lead Sponsor: ProgenaBiome

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2019-09-20
• Study First Submitted QC: 2019-09-20
• Study First Posted: 2019-09-24
• Study Start: 2020-03-02
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-02
• Last Update Posted: 2021-09-05
• Primary Completion: 2023-03
• Study Completion: 2023-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Alzheimer's disease patients	No Intervention	Patients who have been diagnosed with Alzheimer's disease

Primary Outcome Measures

Name	Time	Method
Correlation of Microbiome to Alzheimer's Disease via Relative Abundance Found in Microbiome Sequencing	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

Trial Locations

Locations (1)

ProgenaBiome; 🇺🇸 Ventura, California, United States