Alzheimer DiseaseMiDCRNCT03487380
Taxonomic and Functional Composition of the Intestinal Microbiome: a Predictor of Rapid Cognitive Decline in Patients With Alzheimer's Disease
A study testing Fecal sample collection in people with Alzheimer Disease and Intestinal Microbiota, run by Nantes University Hospital at 2 sites in France.
Trial summary
The objective of the study is to highlight a modification of the composition of the intestinal microbiota associated with the diagnosis of Alzheimer's disease and its most unfavorable form, Rapid Cognitive Decline (DCR). Read more about this study
- Who is it for?
- Ages 70 to 90 years
- Conditions the study is for
- Alzheimer Disease, Intestinal Microbiota
- What is being tested?
- Fecal sample collection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 2 sitesFrance
- Study dates
- 4 Sep 2017to 12 Jun 2023
- Phase
- Interventional
- 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 70 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- For Alzheimer groups without DCR and Alzheimer with DCR:
- patients between 70 and 90 years old
- with mild to moderate Alzheimer's disease (MMSE> 15/30),
- followed in the CMRR of the University Hospital of Nantes or Angers
- having given their informed consent
- For the control group (non-Alzheimer's)
Show all 9Show fewer
- more patients between 70 and 90 years
- consultant for a subjective memory complaint isolated at the CMRR of Nantes or Angers University Hospital,
- having given their informed consent
Who cannot join
- Major patients under tutorship, curatorship or safeguard of justice
- Cognitive disorders possibly related to a metabolic or psychiatric cause
- History of prescription of antibiotic treatment in the last month
- History of acute gastrointestinal illness in the last month
- History of hospitalization for an acute medical pathology or for a surgical procedure in the last month
Trial locations and contacts
2 sites in 1 country.
About this study
The objective of the study is to highlight a modification of the composition of the intestinal microbiota associated with the diagnosis of Alzheimer's disease and its most unfavorable form, Rapid Cognitive Decline (DCR). This identification could lead to diagnostic strategies based on the analysis of the intestinal microbiome, and preventive and curative treatments, based on the modulation of intestinal microbiota
- Conditions
- Alzheimer Disease, Intestinal Microbiota
- Being tested
- Fecal sample collection
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal sample collectionProcedure or surgery
Fecal sample collection
| Study group | Role | What they receive |
|---|---|---|
| Alzheimer with rapid DCR | Experimental | Not described Receives: Procedure: Fecal sample collection |
| Alzheimer without rapid DCR | Experimental | Not described Receives: Procedure: Fecal sample collection |
| Control | Sham comparator | Not described Receives: Procedure: Fecal sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
analysis of the taxonomic and functional composition of the microbiome
("shotgun sequencing"), in patients with DCR (loss of at least 3 points in the MMSE at 1 year.
Measured: 1 year
Secondary outcomes (2)
to determine if there is a specific modification of the composition of the intestinal microbiota of patients with Alzheimer's disease, compared to control group.
Measured: Day 0
create a prognostic score of DCR based on clinical data, including the responses to the MMSE, BREF and MNA questionnaires, and taking into account the microbiota analysis
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2018
- Study start4 Sep 2017
- Primary completion12 Jun 2023
- Study completion12 Jun 2023
Why it stopped: Despite an extension of the planned duration of inclusion and an enrolled patient number inferior than planned, coordinating investigator considered that it was more reasonable to stop inclusions in order to analyze the data already available
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The study will compare three groups of 100 patients, corresponding to 200 patients with Alzheimer disease (whom 100 patients in the rapid cognitive decline group and 100 patients without rapid cognitive decline) and 100 patients in the control group.
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03487380
- Sponsor's protocol ID
- RC17_0162
- Other IDs
- 2017-A02246-47
- Acronym
- MiDCR
- Status last verified
- Jan 2024
- First submitted
- 27 Mar 2018
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Taxonomic and Functional Composition of the Intestinal Microbiome: a Predictor of Rapid Cognitive Decline in Patients With Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT03487380
- Acronym / sponsor ID
- MiDCR / RC17_0162
- Conditions
- Alzheimer Disease, Intestinal Microbiota
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Despite an extension of the planned duration of inclusion and an enrolled patient number inferior than planned, coordinating investigator considered that it was more reasonable to stop inclusions in order to analyze the data already available
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 4 Sep 2017 (actual)
- Primary completion
- 12 Jun 2023 (actual)
- Study completion
- 12 Jun 2023 (actual)
- First posted
- 4 Apr 2018 (actual)
- 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 objective of the study is to highlight a modification of the composition of the intestinal microbiota associated with the diagnosis of Alzheimer's disease and its most unfavorable form, Rapid Cognitive Decline (DCR). This identification could lead to diagnostic strategies based on the analysis of the intestinal microbiome, and preventive and curative treatments, based on the modulation of intestinal microbiota
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The study will compare three groups of 100 patients, corresponding to 200 patients with Alzheimer disease (whom 100 patients in the rapid cognitive decline group and 100 patients without rapid cognitive decline) and 100 patients in the control group.
| Arm | Type | Receives |
|---|---|---|
| Alzheimer with rapid DCR | Experimental | Procedure: Fecal sample collection |
| Alzheimer without rapid DCR | Experimental | Procedure: Fecal sample collection |
| Control | Sham comparator | Procedure: Fecal sample collection |
Who may qualify
- Ages
- 70 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- patients between 70 and 90 years old
- with mild to moderate Alzheimer's disease (MMSE> 15/30),
- followed in the CMRR of the University Hospital of Nantes or Angers
- having given their informed consent
- For the control group (non-Alzheimer's)
Key exclusion criteria (5 listed)
- Major patients under tutorship, curatorship or safeguard of justice
- Cognitive disorders possibly related to a metabolic or psychiatric cause
- History of prescription of antibiotic treatment in the last month
- History of acute gastrointestinal illness in the last month
- History of hospitalization for an acute medical pathology or for a surgical procedure in the last month
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fecal sample collectionFecal sample collection | Procedure or surgery | Alzheimer with rapid DCR, Alzheimer without rapid DCR, Control |
Primary outcome
analysis of the taxonomic and functional composition of the microbiome
Time frame: 1 year
("shotgun sequencing"), in patients with DCR (loss of at least 3 points in the MMSE at 1 year.
2 secondary outcomes
to determine if there is a specific modification of the composition of the intestinal microbiota of patients with Alzheimer's disease, compared to control group.
Time frame: Day 0
create a prognostic score of DCR based on clinical data, including the responses to the MMSE, BREF and MNA questionnaires, and taking into account the microbiota analysis
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Despite an extension of the planned duration of inclusion and an enrolled patient number inferior than planned, coordinating investigator considered that it was more reasonable to stop inclusions in order to analyze the data already available). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fecal sample collection in people with Alzheimer Disease and Intestinal Microbiota, run by Nantes University Hospital at 2 sites in France.
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 9 inclusion and 5 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: stopped early, as of the sponsor's last update on 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: Despite an extension of the planned duration of inclusion and an enrolled patient number inferior than planned, coordinating investigator considered that it was more reasonable to stop inclusions in order to analyze the data already available). Results are not available in the source record.
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?
analysis of the taxonomic and functional composition of the microbiome (time frame: 1 year). 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 1 Feb 2024.