Prevention of Cognitive Decline in ApoE4 Carriers With Subjective Cognitive Decline After EGCG and a Multimodal Intervention
NCT03978052, Not applicable, Completed, Parc de Salut Mar
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Prevention of Cognitive Decline in ApoE4 Carriers With Subjective Cognitive Decline After EGCG and a Multimodal Intervention | ClinicalTrials.gov |
| NCT number | NCT03978052 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 129 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Parc de Salut Mar | ClinicalTrials.gov |
| Conditions | Alzheimer Disease, Cognitive Decline | ClinicalTrials.gov |
| Interventions | EGCG, Placebo EGCG, Healthy lifestyle recommendations, Multimodal lifestyle intervention | ClinicalTrials.gov |
| First posted | 2019-06-06 | ClinicalTrials.gov |
| Last updated | 2024-03-15 | ClinicalTrials.gov |
Registered outcomes 41
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Modified Alzheimer Disease Cooperative Study Preclinical Alzheimer Cognitive Composite (ADCS-PACC) including additional tests of executive functions: the PACC-exe | Screening and 12 months | Changes in the PACC-exe, that include: The Total Recall score from the Free and Cued Selective Reminding Test (FCSRT) (which range from 0-48 words),The Delayed Recall score on the Logical Memory IIa subtest from the Wechsler Memory Scale (which range from 0-25 story units), the Coding Test Total score from the Wechsler Adult Intelligence Scale-Revised (which range from 0-93 symbols), The Montreal Cognitive assessment (MOCA) total score (which range from 0-30 points), and additionally, the Interference score from the Stroop Colour and Word Test (SCWT) and the Five Digit Test. Each of the component change scores is divided by the baseline sample standard deviation of that component, to form standardized z scores. These z scores are summed to form the composite. | ClinicalTrials.gov |
| Secondary | Safety outcome of the intervention with EGCG: AEs and SAEs | Baseline, 6 and 12 | evaluated by means of Incidence, nature, severity and causality of adverse events (AEs) and serious adverse events (SAEs) | ClinicalTrials.gov |
| Secondary | Safety outcome of the intervention with EGCG: Biomarkers thyroid | Baseline, 6 and 12 | Assessment of thyroid function parameters: both TSH and freeT4 within normal values according to the reference population | ClinicalTrials.gov |
| Secondary | Safety outcome of the intervention with EGCG: Biomarkers liver | Baseline, 6 and 12 | Assessment of liver function parameters: ALP and ALT within normal values according to the reference population | ClinicalTrials.gov |
| Secondary | Safety outcome of the intervention with EGCG: Biomarkers | Baseline, 6 and 12 | Assessment of renal function parameters: creatinine within normal values according to the reference population | ClinicalTrials.gov |
| Secondary | Changes in Functional neuronal connectivity (assessed by a functional magnetic resonance imaging) | Screening and 12 months. | Changes in Maps of change in connectivity of the Default mode network Changes in Maps of change in connectivity of the Limbic network Changes in Maps of change in connectivity of the Salience network | ClinicalTrials.gov |
| Secondary | Changes in structural connectivity networks known to be affected in Alzheimer Disease | Screening and 12 months. | Changes in Connectivity changes of the parahippocampus/fornix Changes in Connectivity changes of the cingulum/cingulate fiber bundle Changes in connectivity changes of the caudate heads | ClinicalTrials.gov |
| Other | Changes in Modified Alzheimer Disease Cooperative Study Preclinical Alzheimer Cognitive Composite (ADCS-PACC) including additional tests of executive functions: the PACC-exe | Screening, 6, 12 and 15 months. | Changes in the PACC-exe, that include: The Total Recall score from the Free and Cued Selective Reminding Test (FCSRT) (which range from 0-48 words),The Delayed Recall score on the Logical Memory IIa subtest from the Wechsler Memory Scale (which range from 0-25 story units), the Coding Test Total score from the Wechsler Adult Intelligence Scale-Revised (which range from 0-93 symbols), The Montreal Cognitive assessment (MOCA) total score (which range from 0-30 points), and additionally, the Interference score from the Stroop Colour and Word Test (SCWT) and the Five Digit Test. Each of the component change scores is divided by the baseline sample standard deviation of that component, to form standardized z scores. These z scores are summed to form the composite. | ClinicalTrials.gov |
| Other | Changes in the microbiota composition | Baseline, and 12 months. | For the analysis of microbiota biomarkers our characterization of the microbiome of the samples will include determination of the levels of biodiversity in the samples. Samples will be divided into quartiles in order to label each sample as having low (1st quartile), average (2nd and 3rd quartiles), or high diversity (4th quartile). | ClinicalTrials.gov |
| Other | Change in the dietary patterns (metabolomics) Plasma samples | Baseline, 6, 12 and 15 months | Change in the dietary patterns (metabolomics). Plasma, samples will be collected to analyze the corresponding metabolomes (SFCAs, kynurenine pathway...), we will divide samples into quartiles to label each sample as having low (1st quartile), average (2nd and 3rd quartiles), or high diversity (4th quartile) | ClinicalTrials.gov |
| Other | Change in the dietary patterns (metabolomics) oral fluid | Baseline, 6, 12 and 15 months | Changes in the dietary patterns (metabolomics) of oral fluid will be collected to analyze the corresponding metabolomes for a better understanding of the complexity of the interrelationship of metabolomics in oral fluid and mental health. | ClinicalTrials.gov |
| Other | Change in the dietary patterns (metabolomics). urinary samples | Baseline, 6, 12 and 15 months | Change in the dietary patterns (metabolomics). urinary samples will be collected to analyze the corresponding metabolomes for a better understanding of the complexity of the interrelationship of microbiota, diet, and mental health. | ClinicalTrials.gov |
| Other | Exploratory | At 6 and 12 months | Change in metabolomes derived from the treatment compliance after a multimodal lifestyle change intervention. Urinary samples (24h) will be used to identify objective biomarkers of dietary intake and dietary patterns and to assess the degree of adherence to the Mediterranean diet by monitoring the levels of dietary metabolites (i.e. hydroxytyrosol metabolism, biomarkers of alcohol consumption...). | ClinicalTrials.gov |
| Other | Changes in the semantic verbal fluency | Baseline, 6, 12 and 15 months | Changes in additional cognitive performance scores of: (i) Semantic verbal fluency, "animals" in one minute. (which range from 0-12 words) higher score is better outcome. | ClinicalTrials.gov |
| Other | Changes in the Boston Naming Test | Baseline, 6, 12 and 15 months | Changes in additional cognitive performance scores of: (ii) naming, Boston Naming Test (BNT).: (which range from 0-15 points) higher score is better outcome. | ClinicalTrials.gov |
| Other | Change in attention and working memory | Baseline, 6, 12 and 15 months | Changes in additional cognitive performance scores of: (iii) attention and working memory, | ClinicalTrials.gov |
| Other | Change in the Digit span subtest (WAIS IV) | Baseline, 6, 12 and 15 months | Changes in additional cognitive performance scores of: (iv) Digit span subtest (WAIS IV) , (which range from 0-16 points) | ClinicalTrials.gov |
| Other | Changes in the Olfactory function | Baseline, and 12 months | Changes in the Olfactory function: the University of Pennsylvania Smell Identification Test (UPSIT) is designed to test the function of an individual's olfactory system. It is the gold standard of smell identification tests. Its performance has been related to cognition and it has been widely used as a complementary assessment tool in dementia patients.( which range from 0-40) | ClinicalTrials.gov |
| Other | Changes in the AD biomarkers | Baseline, and 12 months | Changes in the AD biomarkers related to neurodegeneration (NfL), neurotoxicity (GFAP),Tau proteins amyloid-β peptides | ClinicalTrials.gov |
| Other | Changes in biological aging | Baseline and 12 months | Blood sample will be collected for further analysis on biological age biomarkers assessed by epigenetics (biological ageing). The difference between chronological age and biological age, defined as average age acceleration (Δage), will be used to determine individual aging. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 23
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 22349682 | BACKGROUND | PubMed |
| 23332672 | BACKGROUND | PubMed |
| 23732551 | BACKGROUND | PubMed |
| 23969234 | BACKGROUND | PubMed |
| 24039182 | BACKGROUND | PubMed |
| 25681666 | BACKGROUND | PubMed |
| 25771249 | BACKGROUND | PubMed |
| 25961184 | BACKGROUND | PubMed |
| 26086182 | BACKGROUND | PubMed |
| 26594639 | BACKGROUND | PubMed |
| 26696850 | BACKGROUND | PubMed |
| 26852195 | BACKGROUND | PubMed |
| 27302362 | BACKGROUND | PubMed |
| 27474376 | BACKGROUND | PubMed |
| 28088900 | BACKGROUND | PubMed |
| 28359749 | BACKGROUND | PubMed |
| 28484387 | BACKGROUND | PubMed |
| 28735855 | BACKGROUND | PubMed |
| 28740740 | BACKGROUND | PubMed |
| 28766695 | BACKGROUND | PubMed |
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 6
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Selective Reminding Task | Primary outcome | ConductCognition |
| Short Story Recall | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Digit Span Test | Other outcome | ConductCognition |
| Picture Naming Test | Other outcome | ConductCognition |
| Verbal Fluency | Other outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)