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

ProgenaBiome

Status: Withdrawn

Conditions: Alzheimer Disease 6; Alzheimer Disease 8; Alzheimer Disease 16; Alzheimer Disease 18; Alzheimer Disease, Late Onset; Alzheimer Disease 15; Alzheimer Disease 19; Alzheimer Disease 2; Alzheimer Disease 14; Alzheimer Disease, Early Onset; Alzheimer Disease 10; Alzheimer Disease 7; Alzheimer Disease; Alzheimer Disease 5; Alzheimer Disease 17; Alzheimer Disease 9, Late-Onset; Alzheimer Disease 4; Alzheimer Disease 1; Alzheimer Disease 13; Alzheimer Disease Focal; Alzheimer Disease 12; Alzheimer Disease 3; Alzheimer Disease 11

Treatments: Other: No Intervention

Study type: Observational

Funder types: Other

Identifiers

NCT04100889

PRG-007

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

0 participants in 1 patient group

Alzheimer's disease patients

Description:

Patients who have been diagnosed with Alzheimer's disease

Treatment:

Other: No Intervention