ClinicalTrials.gg
RecruitingNCT06986096LIBRA-NETUpdated May 29, 2025

Lifestyle for the BRAin Health - Nutrition and Exercise Training Intervention

An interventional study of Aerobic-strength training and nutritional counseling and Cognitive training and stretching. in Aging, Alzheimer Disease and Life Style, Healthy, sponsored by Slovak Academy of Sciences. Recruiting at 1 site in Slovakia. Open to participants aged 60 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-05-29.

Sponsored by Slovak Academy of Sciences · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Started Sep 2024; still recruiting 2 years 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
60 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 38 studies in Alzheimer Disease with a site in Slovakia — 8 open to participants now, 8 under way, 4 of them phase 3. Alzheimer Disease · Slovakia.

Planned enrollment
37th of 38
40 · median 388
Started
2024
with 2 others
No phase
3 of 38
2 open now
Registered
33rd of 38
by date
Lead sponsor
2 of 38
Slovak Academy of Sciences

Among the 38 studies in Alzheimer Disease with a site in Slovakia, this one is the 37th largest by planned enrollment, is one of 3 that started in 2024, is one of 3 with no phase, and was the 33rd registered.

By phase

38 studies; the count open now beside each. This study's row is marked.

Phase 320 · 3 open
Phase 213 · 2 open
No phasethis study3 · 2 open
Phase 11 · 0 open
Phase 2/31 · 1 open

By the year they started

First in 2003; this study’s year is marked. 3 started in 2024.

Size and results

Median enrollment 388 across the 38 interventional studies. Of the 30 that completed or were terminated, 14 (47%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 38 studies in Alzheimer Disease with a site in Slovakia, or all of them as a file.
02

Study summary

Due to the increasing incidence of dementia and the lack of causal treatment, non-pharmacological interventions represent an attractive and effective therapeutic strategy of neurodegenerative diseases, such as Alzheimer's disease.

The aim of the study is to assess the impact of a supervised 9-month intervention with aerobic-strength training and nutritional counseling compared to cognitive training and stretching on the brain, cognitive and motor functions, metabolism, physical fitnes and plasma markers of neurodegenertion in older adults at increased risk of developing Alzheimer's disease.

03

Conditions studied

  • Aging
  • Alzheimer Disease
  • Life Style, Healthy
  • Exercise
  • Cognitive Impairment
04

Who can participate

Ages eligible
60 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Non-smokers
  • Signed
  • Presence of subjective or mild cognitive impairment (SCI/aMCI)
  • Elevated levels of selected biomarkers confirming the presence of a pathological process characteristic of Alzheimer's disease
  • Absence of any psychological, sociological, or geographical factors that could jeopardize participation in the project.

Exclusion criteria

Exclusion Criteria:

  • Presence of severe cardiovascular, liver, or kidney diseases; advanced or poorly controlled diabetes mellitus ( >7%), treated with insulin or incretin analogs; cancer or any other severe disease as assessed by the responsible physician. A history of cancer treated with chemotherapy or radiotherapy if within less than 5 years post-treatment.
  • Lack of cooperation, inflexible schedule, or problematic transportation.
  • Insufficient functional capacity or presence of comorbidities that prevent participation in the training program (assessment by an internist, cardiologist, neurologist, orthopedic specialist, or other relevant specialists).
  • Presence of a pacemaker or any metal implants ( for MRI examination), or allergy to local anesthetics (contraindication for muscle ).
  • Smoking, alcohol dependence, or addiction to other narcotic substances.
  • Stroke or myocardial infarction within the last year.
  • Long-term treatment for psychiatric disorders - a depressive syndrome is not an exclusion criterion if it is compensated by therapy.
  • Other diseases of the musculoskeletal or nervous system that potentially interfere with the ability to exercise or cognition - such as severe arthritis, Parkinson's disease, significant essential tremor, epilepsy, etc.
  • Concurrent participation in another clinical study.
  • Therapy with cholinesterase inhibitors unless the patient is on a stable dose.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Aerobic-strength training and nutritional counseling

    Elderly volunteers participating in aerobic-strength training and nutritional counseling.

    Behavioral: Aerobic-strength training and nutritional counseling

  • Experimental
    Cognitive training and stretching.

    Elderly volunteers participating in cognitive training combined with stretching training.

    Behavioral: Cognitive training and stretching.

Interventions

  • BehavioralAerobic-strength training and nutritional counseling

    The intervention consists of a structured program that includes aerobic-strength training (1h training, 3 times per week) conducted by professional trainers combined with nutritional counseling.

  • BehavioralCognitive training and stretching.

    The intervention consists of a structured program that includes cognitive training combined with stretching training (90mins training, 2x per week).

06

What researchers measure

Primary outcomes

  1. Impact on Cognitive Functions

    Overall composite score of neuropsychological testing batery (higher score better outcome)

    Time frame: Measurements at the baseline and after 9-month intervention.

  2. Effect of Interventions on Neurodegeneration Markers

    Concentration of plasma neurodegeneration marker pTau 217 (in a subpopulation of patients).

    Time frame: Measurements at the baseline and after 9-month intervention

Secondary outcomes

  1. Computerized Cognitive Tests

    Computerised cognitive testing CogState (learning/working memory score, higher score - better outcome)

    Time frame: Measurements at the baseline and after 9-month intervention.

  2. Well-being

    The World Health Organization Quality of Life questionaire (WHOQOL-BREF), 31 items, highre score better QoL.

    Time frame: Measurements at the baseline and after 9-month intervention.

  3. Glucose metabolism

    oral glucose tolerance test will be perfromed to detect level of glucose intolerance (impaired glucose tolerance)

    Time frame: Measurements at the baseline and after 9-month intervention.

  4. MRI of the Brain

    Imaging studies to assess structural adaptation of the brain (hippocampal volume).

    Time frame: Measurements at the baseline and after 9-month intervention.

  5. Adherence

    Evaluation of participant adherence to the intervention protocol.

    Time frame: Adherence will be recorded during the 9-month intervention period.

  6. Olfactory Function

    Olfactory function screening test (The Sniffin' Sticks test kit).

    Time frame: Measurements at baseline and after 9-month intervention.

  7. Microbiome Composition

    Determination of feacal microbiome composition (16S sequencing).

    Time frame: Measurements at baseline and after 9-month intervention.

07

Study locations

1 of 1 sites recruiting
  • Biomedical Research Center Slovak Academy of Sciences
    Bratislava, 84505, Slovakia
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2024 (actual). Primary completion is estimated for Dec 2026, 27 months after the start.

Of 882 non-industry interventional studies with no phase under Alzheimer Disease, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 51. This study's planned 27 months is close to that.

Counting every sponsor, half of 959 studies reached it within 29 months; a quarter within 15 and three quarters within 51.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 15, 2024
First posted
May 22, 2025
StartActual
Sep 1, 2024
Primary completionEst.
Dec 2026
CompletionEst.
Dec 2026
Last update
May 29, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 29, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06986096
Lead sponsor
Slovak Academy of Sciences
Responsible party
Barbara Ukropcová, MD, PhD (Professor, Slovak Academy of Sciences) — Principal investigator
First posted
May 22, 2025
Start date
Sep 1, 2024
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
May 29, 2025

Study contacts

Barbora Ukropcova, Prof.
Contact
barbara.ukropcova@sabva.sk
+421911643630
Barbora Ukropcova, Prof.
principal investigator · Biomedical Research Center Slovak Academy of Science

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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