Neurodegenerative DiseasesEarly Phase 1NCT06181513
Probiotics in Mild Alzheimer's Disease
A Early Phase 1 study testing Probiotic Blend Capsule in people with Neurodegenerative Diseases and Cognition Disorders in Old Age, run by University of Nicosia at 1 site in Cyprus.
Trial summary
The main objective is to investigate whether administration of probiotics to patients with mild Alzheimer's Disease (AD) reduces neuroinflammation, improves cognitive function and modifies neurophysiological measures, compared to a patient group that receives placebo (no active probiotics). Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Neurodegenerative Diseases, Cognition Disorders in Old Age
- What is being tested?
- Probiotic Blend Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteCyprus
- Study dates
- 19 Dec 2022to 1 Dec 2025
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Adults ≥65 years, able to give consent
- Mini-Mental State Examination (MMSE) scores 19-23 (mild AD)
- approximately equal male:female ratio
Who cannot join
- Inability to give consent
- other neurological disease
- relevant psychiatric disorders (e.g. major depression)
- gastrointestinal/metabolic conditions
- history of alcohol/substance dependence
- use of systemic antibiotics in the previous 6 months
Show all 15Show fewer
- corticosteroid use
- immune stimulating medications
- immunosuppressive agents
- probiotics consumption in the previous 6 months.
- immunosuppression
- structural heart disease
- neutropenia
- radiation
- active intestinal disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Cyprus1 site, 1 recruiting
- Recruiting
The Cyprus Institute of Neurology and Genetics
Nicosia
Ioanna Kousiappa, ioannak@cing.ac.cy
About this study
Official title: Effect of Probiotics on Cognitive Functioning of Patients With Mild Alzheimer's Disease
The main objective is to investigate whether administration of probiotics to patients with mild Alzheimer's Disease (AD) reduces neuroinflammation, improves cognitive function and modifies neurophysiological measures, compared to a patient group that receives placebo (no active probiotics).
Read the detailed description
We will measure specific blood inflammatory markers (primary outcome), neurophysiological activity, cognitive test scores, microbiome composition and dietary habits of participants in the probiotics and placebo group.
- Being tested
- Probiotic Blend Capsule
- Keywords
- probiotics, Electroencephalogram (EEG), cognitive function, Alzheimer's Disease, neuropsychological testing, Electrocardiogram (EKG)
- Medical subject headings
- Neurodegenerative Diseases, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic Blend CapsuleDrug
Also called Ultrabiotique Equilibre 30 Vitavea
20 million CFU (Lactobacillus paracasei, Lactobacillus plantarum, Lactobacillus rhamnosus, Lactobacillus helveticus, Bifidobacterium breve)
| Study group | Role | What they receive |
|---|---|---|
| Probiotics | Experimental | Participants received 1 capsule daily of probiotics, administered orally for 16 weeks. Receives: Drug: Probiotic Blend Capsule |
| Placebo | Placebo comparator | Participants received 1 capsule daily of placebo, administered orally for 16 weeks. Receives: Drug: Probiotic Blend Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of inflammatory markers
Peripheral inflammation markers implicated in the pathogenesis of mild-AD (pro-inflammatory cytokines: IL-6, IL-1β, CXCL2, NLRP3; anti-inflammatory cytokines: IL-10. Isolated from blood plasma.
Measured: Baseline (week 0), end of study (week 16)
Secondary outcomes (6)
Cognitive function and neuropsychological scores
Mini-Mental State Examination (MMSE)
Measured: Baseline (week 0), end of study (week 16)
Cognitive function and neuropsychological scores
Montreal Cognitive Assessment (MoCA)
Measured: Baseline (week 0), end of study (week 16)
Cognitive function and neuropsychological scores
Rey-Osterrieth complex figure test
Measured: Baseline (week 0), end of study (week 16)
Cognitive function and neuropsychological scores
Wechsler Abbreviated Scale of Intelligence (WASI)
Measured: Baseline (week 0), end of study (week 16)
Neurophysiological activity changes
Electroencephalogram (EEG) and electrocardiogram (EKG) measured at rest (eyes open, eyes closed).
Measured: Baseline (week 0), end of study (week 16)
Microbiome profile
16S rDNA gene sequencing for bacterial identification, taxonomic profiling.
Measured: Baseline (week 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2023
- Study start19 Dec 2022
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurodegenerative DiseasesStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nicosia
- Sponsor type
- University, hospital or other
- Collaborators
- Cyprus Institute of Neurology and Genetics
- Responsible party
- Principal investigator, Nicoletta Nicolaou, University of Nicosia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06181513
- Sponsor's protocol ID
- AARG-NTF-22-928616
- Status last verified
- Dec 2024
- First submitted
- 8 Dec 2023
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Probiotics on Cognitive Functioning of Patients With Mild Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT06181513
- Acronym / sponsor ID
- AARG-NTF-22-928616
- Keywords
- probiotics, Electroencephalogram (EEG), cognitive function, Alzheimer's Disease, neuropsychological testing, Electrocardiogram (EKG)
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of NicosiaUniversity, hospital or other
- Collaborators
- Cyprus Institute of Neurology and Genetics
- Study start
- 19 Dec 2022 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 26 Dec 2023 (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 main objective is to investigate whether administration of probiotics to patients with mild Alzheimer's Disease (AD) reduces neuroinflammation, improves cognitive function and modifies neurophysiological measures, compared to a patient group that receives placebo (no active probiotics).
Detailed description
We will measure specific blood inflammatory markers (primary outcome), neurophysiological activity, cognitive test scores, microbiome composition and dietary habits of participants in the probiotics and placebo group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotics | Experimental | Drug: Probiotic Blend CapsuleParticipants received 1 capsule daily of probiotics, administered orally for 16 weeks. |
| Placebo | Placebo comparator | Drug: Probiotic Blend CapsuleParticipants received 1 capsule daily of placebo, administered orally for 16 weeks. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Adults ≥65 years, able to give consent
- Mini-Mental State Examination (MMSE) scores 19-23 (mild AD)
- approximately equal male:female ratio
Key exclusion criteria (15 listed)
- Inability to give consent
- other neurological disease
- relevant psychiatric disorders (e.g. major depression)
- gastrointestinal/metabolic conditions
- history of alcohol/substance dependence
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 |
|---|---|---|
| Probiotic Blend CapsuleAlso: Ultrabiotique Equilibre 30 Vitavea20 million CFU (Lactobacillus paracasei, Lactobacillus plantarum, Lactobacillus rhamnosus, Lactobacillus helveticus, Bifidobacterium breve) | Drug | Placebo, Probiotics |
Primary outcome
Level of inflammatory markers
Time frame: Baseline (week 0), end of study (week 16)
Peripheral inflammation markers implicated in the pathogenesis of mild-AD (pro-inflammatory cytokines: IL-6, IL-1β, CXCL2, NLRP3; anti-inflammatory cytokines: IL-10. Isolated from blood plasma.
6 secondary outcomes
Cognitive function and neuropsychological scores
Time frame: Baseline (week 0), end of study (week 16)
Cognitive function and neuropsychological scores
Time frame: Baseline (week 0), end of study (week 16)
Cognitive function and neuropsychological scores
Time frame: Baseline (week 0), end of study (week 16)
Cognitive function and neuropsychological scores
Time frame: Baseline (week 0), end of study (week 16)
Neurophysiological activity changes
Time frame: Baseline (week 0), end of study (week 16)
Microbiome profile
Time frame: Baseline (week 0)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Probiotic Blend Capsule in people with Neurodegenerative Diseases and Cognition Disorders in Old Age, run by University of Nicosia at 1 site in Cyprus.
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 3 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cyprus. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicoletta Nicolaou (+35722471903, nicolaou.nic@unic.ac.cy), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of inflammatory markers (time frame: Baseline (week 0), end of study (week 16)). 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 5 Dec 2024.