Life-style and multi-omics to approach cognitive decline and dementia

A comprehensive life-style and multi-omics integrative approach to study metabolic processes related to cognitive function, cognitive decline and progression to dementia

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN52227045

Enrollment

300

Registered

2023-05-16

Start date

2023-06-01

Completion date

Unknown

Last updated

2023-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Subjective cognitive decline and mild cognitive impairment Mental and Behavioural Disorders

Interventions

A prospective observational cohort study will be conducted on over 300 men and women, aged 45-80 years, with subjective cognitive decline (SCD) or mild cognitive impairment (MCI), who attend the Unit

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Men and women aged between 45-80 years old 2. Mini-Mental State Examination (MMSE) = 26, hospital anxiety scale = , hospital depression scale = 11

Exclusion criteria

Exclusion criteria: 1. Mini-Mental State Examination (MMSE) <26 or inability to give informed consent 2. Diagnosis of dementia 3. Presence of depressive symptoms (Geriatric Depression Scale =5) 4. Major medical or psychiatric condition 5. Evidence of impairment due to psychoactive drugs 6. Alcohol or drug abuse 7. Inability to perform imaging studies (i.e.CAT, MR) 8. Other conditions under the neurologist criteria

Design outcomes

Primary

Measure	Time frame
Cognitive decline measured by a battery of neuropsychological tests assessing orientation, attention, language, praxis, learning memory and executive function (Mini-Mental State Examination (MMSE), the Spanish version of the Yesavage abbreviated questionnaire (GDS), the Hospital Anxiety and Depression Scale (HADS), the Rami Cognitive reserve questionnaire (CRQ), the Subjective Cognitive Impairment Questionnaire (SCD-Q), the Activities of Daily Living (ADL) scale, Direct and inverse digits (Test Barcelona), WAIS-III, TMT-A and TMT-B, Symbol Digit Modality test, Boston Naming Test (abbreviated version), a semantic and phonological verbal fluency test, Rey–Osterrieth complex figure, Barcelona-II), Free and cued selective reminding test (Buschke), and the Clock Drawing Test) at baseline and every 2 years during the follow-up.	—

Measure

Time frame

Cognitive decline measured by a battery of neuropsychological tests assessing orientation, attention, language, praxis, learning memory and executive function (Mini-Mental State Examination (MMSE), the Spanish version of the Yesavage abbreviated questionnaire (GDS), the Hospital Anxiety and Depression Scale (HADS), the Rami Cognitive reserve questionnaire (CRQ), the Subjective Cognitive Impairment Questionnaire (SCD-Q), the Activities of Daily Living (ADL) scale, Direct and inverse digits (Test Barcelona), WAIS-III, TMT-A and TMT-B, Symbol Digit Modality test, Boston Naming Test (abbreviated version), a semantic and phonological verbal fluency test, Rey–Osterrieth complex figure, Barcelona-II), Free and cued selective reminding test (Buschke), and the Clock Drawing Test) at baseline and every 2 years during the follow-up.

—

Secondary

Measure	Time frame
Secondary outcome measures are assessed at baseline and follow-up: 1. Circulating and fecal metabolites measured using (multi-omics platform) gas chromatography-high-resolution mass spectrometry (GC-HRMS), liquid chromatography (LC)-HRMS and proton nuclear magnetic resonance (H-NMR) 2. Non-coding RNA measured using rt-PCR/RNAseq 3. Gut and salival microbiota measured using 16S, metagenomics 4. Markers of vulnerable aging i.e., inflammation, oxidation, and other specific markers measured with appropriate methodologies accordingly i.e., ELISA, MAGPIX) 5. Brain metabolism and structure measured using 18F-FDG-PET, CT-scan, NMR 6. Lifestyle, environmental factors and cognitive tests measured using specific questionnaires such as food frequency questionnaire (FFQ), healthy lifestyle scoring (HLS), quality of life (QoL), and actigraphy with ActiGraph ActiLife 7. Genetics and epigenetics tags measured using RT-PCR, methylation kit, sequencing-Illumina 8. Proteomic and transcriptomic analyses measured using external platforms and services	—

Measure

Time frame

Secondary outcome measures are assessed at baseline and follow-up: 1. Circulating and fecal metabolites measured using (multi-omics platform) gas chromatography-high-resolution mass spectrometry (GC-HRMS), liquid chromatography (LC)-HRMS and proton nuclear magnetic resonance (H-NMR) 2. Non-coding RNA measured using rt-PCR/RNAseq 3. Gut and salival microbiota measured using 16S, metagenomics 4. Markers of vulnerable aging i.e., inflammation, oxidation, and other specific markers measured with appropriate methodologies accordingly i.e., ELISA, MAGPIX) 5. Brain metabolism and structure measured using 18F-FDG-PET, CT-scan, NMR 6. Lifestyle, environmental factors and cognitive tests measured using specific questionnaires such as food frequency questionnaire (FFQ), healthy lifestyle scoring (HLS), quality of life (QoL), and actigraphy with ActiGraph ActiLife 7. Genetics and epigenetics tags measured using RT-PCR, methylation kit, sequencing-Illumina 8. Proteomic and transcriptomic analyses measured using external platforms and services

—

Countries

Spain

Contacts

Public ContactNeus Rodríguez Nogales

neus.rodriguez@iispv.cat+34 977 759 396

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026