A Non-Interventional Pilot Study to Explore the Role of G... | NCT04100889

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

NCT04100889

Sponsor

ProgenaBiome

Status

Withdrawn

Last Update Posted

Jun 5, 2025Actual

Enrollment

0Actual

Phase

Not provided

Conditions

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

Interventions

No Intervention

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Sep 2021

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Company focus shifted

Expanded Access Info

Start Date

Mar 2, 2020Actual

Primary Completion Date

Mar 2030Estimated

Completion Date

Jul 2030Estimated

First Submitted Date

Sep 20, 2019

First Submission Date that Met QC Criteria

Sep 20, 2019

First Posted Date

Sep 24, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 2, 2025

Last Update Posted Date

Jun 5, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Conditions Module

Conditions

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

Keywords

Microbiome

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Year

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Alzheimer's disease patients		Patients who have been diagnosed with Alzheimer's disease	Other: No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No Intervention	Other	There is no intervention for this study.	Alzheimer's disease patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Correlation of Microbiome to Alzheimer's Disease via Relative Abundance Found in Microbiome Sequencing	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	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients who are 18 years of age or older and have been diagnosed with Alzheimer's disease.

Sampling Method

Probability Sample

Name	Affiliation	Role
Sabine Hazan, MD	ProgenaBiome	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
ProgenaBiome		Ventura	California	93003	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Only aggregated and deidentified data will be shared with other researchers

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D000544	Alzheimer Disease
C536594	Alzheimer disease type 1
C536595	Alzheimer disease type 2
C536598	Alzheimer disease, familial, type 3
C536596	Alzheimer disease type 4
C566578	Alzheimer Disease 5
C565325	Alzheimer Disease 6
C565251	Alzheimer Disease 7
C564622	Alzheimer Disease 8
C563834	Alzheimer Disease 9
C566465	Alzheimer Disease 10
C565228	Alzheimer Disease 11
C567022	Alzheimer Disease 12
C567000	Alzheimer Disease 13
C566999	Alzheimer Disease 14
C566998	Alzheimer Disease 15
C567463	Alzheimer Disease 16

ID	Term
D003704	Dementia
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D024801	Tauopathies
D019636	Neurodegenerative Diseases
D019965	Neurocognitive Disorders
D001523	Mental Disorders