Mild Cognitive ImpairmentEPICURONCT04705220

Effect of Nutritional Supplementation With Turmeric on the Cognitive Performance of Subjects With Metabolic Syndrome

A study testing MERIVA® Tablets in people with Mild Cognitive Impairment, run by Indena S.p.A at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 60 years and older
Conditions the study is for: Mild Cognitive Impairment
What is being tested?: MERIVA® Tablets
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 85 participants
Where: 1 siteItaly
Study dates: 8 Apr 2022to 19 Dec 2025
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 60 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female subjects.
Subjects aged ≥ 60 years.
Subjects with Metabolic Syndrome diagnosed according to standard criteria:
Presence of abdominal obesity (waist circumference> 94 cm for males and> 80 cm for females).
In addition, at least two of the following alterations:
Fasting blood glucose ≥ 100 mg / dl.

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Triglycerides ≥ 150 mg / dl.
HDL cholesterol <40 mg / dl for males, <50 mg / dl for females.
Arterial hypertension (≥ 135/85 mmHg).
Subjects who understand the nature of the study and provide their informed consent to participate.
Subjects willing and able to participate in the visits and in the procedures foreseen by the study protocol.

Who cannot join

Subjects with dementia with MMSE <24 test and on therapy with cholinesterase inhibitors or memantine*.
Subjects with serious concomitant internal medical conditions or with neurological pathologies capable of causing cognitive dysfunction.
Subjects with hepato-biliary disorders, including bile duct obstruction, cholangitis, gallstones.
Subjects addicted to alcohol or drugs, or treated with psychotropic drugs at the time of enrollment.
Subjects with known or suspected allergy or hypersensitivity to turmeric or other components of the experimental / placebo product.
Subjects with Mild Cognitive Impairment (MCI) and in experimental therapy with Alzheimer's disease drugs.

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Subjects who are participating or have participated in other clinical studies within 30 days before enrollment.
Subjects unable to sign the Informed Consent to Participation.
In case of conversion to dementia the Subjects will be kept in the study, will be subjected to the most appropriate therapies provided for the dementia pathology but will not enter the subsequent statistical evaluations.

Trial locations and contacts

1 site in 1 country.

Italy1 site

S.C. di Endocrinologia e Diabetologia, Policlinico Universitario "Agostino Gemelli"
Roma, 00168

Other trials in Italy

About this study

The EPICURO study aims to demonstrate the beneficial effects of a 6-month dietary supplementation with an improved bioavailable turmeric (MERIVA®) on inflammatory, oxidative and metabolic parameters together with cognitive performance, potentially resulting in the reduction of the risk of cognitive decline in subjects, male and female, with Metabolic Syndrome. The results obtained will provide novel insights on MERIVA® for improving the prevention of age-related cognitive decline and Alzheimer's disease.

Read the detailed description

This single-center trial will be a placebo-controlled, double-blind, randomized, 2 parallel groups study. The subjects will be randomly allocated to one of two treatment groups (MERIVA® or placebo). The duration of the supplementation is 6 months. The total sample size at baseline is 100 subjects aged 60+ years with Metabolic Syndrome, and therefore at risk of cognitive decline but without definite cognitive pathologies.

The primary objective of the study is the evaluation of the effect of nutritional supplementation with MERIVA® on the cognitive performance of subjects with Metabolic Syndrome, and therefore at risk of cognitive decline, with a view to maintaining the homeostatic balance of the function.

The secondary objectives of the study are:

Evaluation of the effect of nutritional supplementation with turmeric (MERIVA®) on memory, executive and attention functions, language, neuropsychiatric profile and daily living ability of Subjects with Metabolic Syndrome;
Evaluation of the effect of nutritional supplementation with turmeric (MERIVA®) on the body composition of Subjects with Metabolic Syndrome;
Evaluation of the effect of nutritional supplementation with turmeric (MERIVA®) on the arterial properties of Subjects with Metabolic Syndrome;
Evaluation of the effect of nutritional supplementation with turmeric (MERIVA®) on glucose metabolism and on the lipid and immune structure of Subjects with Metabolic Syndrome;
Evaluation of the influence of gender / gender on the response to nutritional supplementation with turmeric (MERIVA®) in Subjects with Metabolic Syndrome;
Confirmation of the safety profile of nutritional supplementation with turmeric (MERIVA®) in Subjects with Metabolic Syndrome.

Conditions: Mild Cognitive Impairment
Being tested: MERIVA® Tablets, Placebo Tablets
Keywords: Metabolic Syndrome, Curcumin, Mild Cognitive Impairment, Nutraceutical, Nutritional Supplementation
Medical subject headings: Cognitive Dysfunction, Metabolic Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MERIVA® TabletsDietary supplement
The treatment corresponds to 1 g / day of experimental product (corresponding to about 200 mg of curcuminoids).
Placebo TabletsOther
The composition of placebo includes the same components of the treatment tablets, except for the active substance.

Study groups in NCT04705220
Study group	Role	What they receive
Nutritional Supplementation with Test Product	Experimental	Subjects will receive 1 tablet of MERIVA® in two administrations per day (one in the morning, one in the evening during meals) for a period of 6 months. This treatment corresponds to 1 g / day of experimental product (corresponding to about 200 mg of curcuminoids). Receives: Dietary Supplement: MERIVA® Tablets
Control Group without Nutritional Supplementation	Placebo comparator	Subjects will receive 1 tablet of placebo in two administrations per day (one in the morning, one in the evening during meals) for a period of 6 months. Receives: Other: Placebo Tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

Change from Baseline of Mini-Mental State Examination (MMSE) Test
Percentage of subjects showing an improvement in performance in Mini-Mental State Examination (MMSE) test in comparison to baseline, defined as an increase of more than 2 points in the test. A difference between the group treated with MERIVA® versus placebo of at least 20% in the proportion of subjects with clinical improvement as defined above is considered clinically relevant. The differences between genders are considered.
Measured: Change from Baseline (T0) to 6 months of treatment (T6) and 12 months of treatment (T12).
Change from Baseline of Montreal Cognitive Assessment (MOCA) Test
Percentage of subjects showing an improvement in performance in Montreal Cognitive Assessment (MOCA) test in comparison to baseline, defined as an increase of more than 2 points in the test. A difference between the group treated with MERIVA® versus placebo of at least 20% in the proportion of subjects with clinical improvement as defined above is considered clinically relevant. The differences between genders are considered.
Measured: Change from Baseline (T0) to 6 months of treatment (T6) and 12 months of treatment (T12).

Secondary outcomes (14)

Change from Baseline of Rey's Auditory Verbal Learning Test (RAVLT) Test
Evaluation in comparison to baseline of the neuropsychological measurement performed regarding memory tests (Rey's Auditory Verbal Learning Test - RAVLT). Any differences between the groups treated with MERIVA® versus placebo will be recorded.
The differences between genders are considered.
Measured: Change from Baseline (T0) to 6 months of treatment (T6) and 12 months of treatment (T12).
Change from Baseline of Trail Making Test (TMT) Test
Evaluation in comparison to baseline of the neuropsychological measurement performed regarding executive functions and attention (Trail Making Test - TMT). Any differences between the groups treated with MERIVA® versus placebo will be recorded.
The differences between genders are considered.
Measured: Change from Baseline (T0) to 6 months of treatment (T6) and 12 months of treatment (T12).
Change from Baseline of Multiple Features Target Cancellation (MFTC) Test
Evaluation in comparison to baseline of the neuropsychological measurement performed regarding executive functions and attention (Multiple Features Target Cancellation - MFTC). Any differences between the groups treated with MERIVA® versus placebo will be recorded.
The differences between genders are considered.
Measured: Change from Baseline (T0) to 6 months of treatment (T6) and 12 months of treatment (T12).
Change from Baseline of Phonological and Semantic Verbal Fluidity (FVS) Test
Evaluation in comparison to baseline of the neuropsychological measurement performed regarding language (Phonological and Semantic Verbal Fluidity - FVS). Any differences between the groups treated with MERIVA® versus placebo will be recorded.
The differences between genders are considered.
Measured: Change from Baseline (T0) to 6 months of treatment (T6) and 12 months of treatment (T12).
Change from Baseline of Geriatric Depression Scale (GDS) Test
Evaluation in comparison to baseline of the neuropsychological measurement performed regarding a neuropsychiatric scale (Geriatric Depression Scale - GDS). Any differences between the groups treated with MERIVA® versus placebo will be recorded.
The differences between genders are considered.
Measured: Change from Baseline (T0) to 6 months of treatment (T6) and 12 months of treatment (T12).
Change from Baseline of Neuro-Psychiatric Inventory (NPI) Test
Evaluation in comparison to baseline of the neuropsychological measurement performed regarding a neuropsychiatric scale (Neuro-Psychiatric Inventory - NPI). Any differences between the groups treated with MERIVA® versus placebo will be recorded.
The differences between genders are considered.
Measured: Change from Baseline (T0) to 6 months of treatment (T6) and 12 months of treatment (T12).
Change from Baseline of Basic Activities of Daily Living (BADL) Test
Evaluation in comparison to baseline of the neuropsychological measurement performed regarding the ability to live everyday (Basic Activities of Daily Living - BADL). Any differences between the groups treated with MERIVA® versus placebo will be recorded.
The differences between genders are considered.
Measured: Change from Baseline (T0) to 6 months of treatment (T6) and 12 months of treatment (T12).
Change from Baseline of Instrumental Activities of Daily Living (IADL) Test
Evaluation in comparison to baseline of the neuropsychological measurement performed regarding the ability to live everyday (Instrumental Activities of Daily Living - IADL). Any differences between the groups treated with MERIVA® versus placebo will be recorded.
The differences between genders are considered.
Measured: Change from Baseline (T0) to 6 months of treatment (T6) and 12 months of treatment (T12).
Change from Baseline of Stroop Test - Short Version
Evaluation in comparison to baseline of the neuropsychological measurement performed regarding executive functions and attention (Stroop test short version). Any differences between the groups treated with MERIVA® versus placebo will be recorded.
The differences between genders are considered.
Measured: Change from Baseline (T0) to 6 months of treatment (T6) and 12 months of treatment (T12).
Change from Baseline of Bioelectrical Impedance (BIA) Assessment
Evaluation in comparison to baseline of body composition by bioelectrical impedance (BIA). Any differences between the groups treated with MERIVA® versus placebo will be recorded.
The differences between genders are considered.
Measured: Change from Baseline (T0) to 6 months of treatment (T6) and 12 months of treatment (T12).
Change from Baseline of Metabolism Parameters measured in Blood
Evaluation in comparison to baseline of metabolism changes (blood panel including: total cholesterol, Low-Density Lipoproteins, High-Density Lipoproteins, insulin, triglycerides, glucose, creatinine, uric acid, electrolytes, hepatic transaminases, gamma-glutamyltransferase, total proteins). In particular, any differences in terms of fasting blood glucose reduction and Homeostatic Model Assessment (HOMA) Index between the groups treated with MERIVA® versus placebo will be recorded.
The differences between genders are considered.
Measured: Change from Baseline (T0) to 6 months of treatment (T6) and 12 months of treatment (T12).
Change from Baseline of Lipid and Immune Profile measured in Blood
Evaluation in comparison to baseline of the lipid and immune profile of subjects treated with MERIVA® versus placebo. In particular, an omic-type approach will reveal alterations in lipid and energy metabolism, including lipoproteins, low molecular weight metabolites and individual lipid molecules, together with their degree of (poly) (non) saturation (blood panel including: leptin, adiponectin, Brain-derived Neurotrophic Factor, proinflammatory mediators such as Tumor Necrosis Factor alpha, interleukin-1 beta and interleukin-6, prostaglandins and reactive species of oxygen / nitrogen, inflammasome).
The differences between genders are considered.
Measured: Change from Baseline (T0) to 6 months of treatment (T6) and 12 months of treatment (T12).
Change from Baseline of Brain-Derived Neurotrophic Factor (BDNF) and p66Shc Gene Expression measured in Blood
Evaluation in comparison to baseline of the lipid and immune profile of subjects treated with MERIVA® versus placebo. In particular, a sample of Peripheral Blood Mononuclear Cells (PBMC) will be separated for the measurement of the expression, by means of real-time Polymerase Chain Reaction (RT-PCR), of the neurotrophin Brain-Derived Neurotrophic Factor (BDNF) and of the p66Shc gene, which are involved in the response to lifestyle changes, including diets and exercise.
The differences between genders are considered.
Measured: Change from Baseline (T0) to 6 months of treatment (T6).
Rate and Characterization of Adverse Events occurred to Subjects
Evaluation of the number, rate and characteristics of the adverse events occurring to subjects treated with MERIVA® versus placebo.
The differences between genders are considered.
Measured: Pre-Screening (T-1) / Baseline (T0) / After 3 months of treatment (T3) / After 6 months of treatment (T6) / After 12 months of treatment (T12).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Apr 202219 Dec 2025

First posted12 Jan 2021
Study start8 Apr 2022
Primary completion16 Oct 2025
Study completion19 Dec 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (12)Papers the sponsor has linked to this study.
Other trials for Mild Cognitive ImpairmentStudies 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: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Model description: This is a double-blind, randomized, single-center clinical trial. Patients enrolled will be randomized in a 1:1 ratio between groups and sexes to receive the test product MERIVA® (Group A) or its correspondent placebo (Group B).
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 85 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04705220
Sponsor's protocol ID: CUR-01-2019
Acronym: EPICURO
Status last verified: Dec 2025
First submitted: 6 Dec 2019
Last updated: 2 Feb 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Petersen RC, Caracciolo B, Brayne C, Gauthier S, Jelic V, Fratiglioni L. Mild cognitive impairment: a concept in evolution. J Intern Med. 2014 Mar;275(3):214-28. doi: 10.1111/joim.12190.
PubMed 24605806
McKhann GM, Knopman DS, Chertkow H, Hyman BT, Jack CR Jr, Kawas CH, Klunk WE, Koroshetz WJ, Manly JJ, Mayeux R, Mohs RC, Morris JC, Rossor MN, Scheltens P, Carrillo MC, Thies B, Weintraub S, Phelps CH. The diagnosis of dementia due to Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement. 2011 May;7(3):263-9. doi: 10.1016/j.jalz.2011.03.005. Epub 2011 Apr 21.
PubMed 21514250
Mrak RE, Griffin WS. Potential inflammatory biomarkers in Alzheimer's disease. J Alzheimers Dis. 2005 Mar;8(4):369-75. doi: 10.3233/jad-2005-8406.
PubMed 16556968
Schrijvers EM, Witteman JC, Sijbrands EJ, Hofman A, Koudstaal PJ, Breteler MM. Insulin metabolism and the risk of Alzheimer disease: the Rotterdam Study. Neurology. 2010 Nov 30;75(22):1982-7. doi: 10.1212/WNL.0b013e3181ffe4f6.
PubMed 21115952
Matsuzaki T, Sasaki K, Tanizaki Y, Hata J, Fujimi K, Matsui Y, Sekita A, Suzuki SO, Kanba S, Kiyohara Y, Iwaki T. Insulin resistance is associated with the pathology of Alzheimer disease: the Hisayama study. Neurology. 2010 Aug 31;75(9):764-70. doi: 10.1212/WNL.0b013e3181eee25f. Epub 2010 Aug 25.
PubMed 20739649
Cicero AFG, Fogacci F, Morbini M, Colletti A, Bove M, Veronesi M, Giovannini M, Borghi C. Nutraceutical Effects on Glucose and Lipid Metabolism in Patients with Impaired Fasting Glucose: A Pilot, Double-Blind, Placebo-Controlled, Randomized Clinical Trial on a Combined Product. High Blood Press Cardiovasc Prev. 2017 Sep;24(3):283-288. doi: 10.1007/s40292-017-0206-3. Epub 2017 May 23.
PubMed 28537012
Giugliano G, Salemme A, De Longis S, Perrotta M, D'Angelosante V, Landolfi A, Izzo R, Trimarco V. Effects of a new nutraceutical combination on cognitive function in hypertensive patients. Immun Ageing. 2018 Feb 7;15:7. doi: 10.1186/s12979-017-0113-4. eCollection 2018.
PubMed 29445414
Cox KH, Pipingas A, Scholey AB. Investigation of the effects of solid lipid curcumin on cognition and mood in a healthy older population. J Psychopharmacol. 2015 May;29(5):642-51. doi: 10.1177/0269881114552744. Epub 2014 Oct 2.
PubMed 25277322
Tabrizi R, Vakili S, Lankarani KB, Akbari M, Mirhosseini N, Ghayour-Mobarhan M, Ferns G, Karamali F, Karamali M, Taghizadeh M, Kouchaki E, Asemi Z. The Effects of Curcumin on Glycemic Control and Lipid Profiles Among Patients with Metabolic Syndrome and Related Disorders: A Systematic Review and Metaanalysis of Randomized Controlled Trials. Curr Pharm Des. 2018;24(27):3184-3199. doi: 10.2174/1381612824666180828162053.
PubMed 30156145
Albert MS, DeKosky ST, Dickson D, Dubois B, Feldman HH, Fox NC, Gamst A, Holtzman DM, Jagust WJ, Petersen RC, Snyder PJ, Carrillo MC, Thies B, Phelps CH. The diagnosis of mild cognitive impairment due to Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement. 2011 May;7(3):270-9. doi: 10.1016/j.jalz.2011.03.008. Epub 2011 Apr 21.
PubMed 21514249
Berry A, Cirulli F. The p66(Shc) gene paves the way for healthspan: evolutionary and mechanistic perspectives. Neurosci Biobehav Rev. 2013 Jun;37(5):790-802. doi: 10.1016/j.neubiorev.2013.03.005. Epub 2013 Mar 20.
PubMed 23524280
Berry A, Bucci M, Raggi C, Eriksson JG, Guzzardi MA, Nuutila P, Huovinen V, Iozzo P, Cirulli F. Dynamic changes in p66Shc mRNA expression in peripheral blood mononuclear cells following resistance training intervention in old frail women born to obese mothers: a pilot study. Aging Clin Exp Res. 2018 Jul;30(7):871-876. doi: 10.1007/s40520-017-0834-4. Epub 2017 Sep 26.
PubMed 28952131

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Nutritional Supplementation With Turmeric on the Cognitive Performance of Subjects With Metabolic Syndrome
ClinicalTrials.gov ID: NCT04705220
Acronym / sponsor ID: EPICURO / CUR-01-2019
Conditions: Mild Cognitive Impairment
Keywords: Metabolic Syndrome, Curcumin, Mild Cognitive Impairment, Nutraceutical, Nutritional Supplementation
Study type: Interventional
Recruitment status: Completed
Enrolment: 85 participants (actual)
Lead sponsor: Indena S.p.AIndustry (pharma, biotech, devices)
Collaborators: Istituto Superiore di Sanità, Sintesi Research Srl
Study start: 8 Apr 2022 (actual)
Primary completion: 16 Oct 2025 (actual)
Study completion: 19 Dec 2025 (actual)
First posted: 12 Jan 2021 (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.

Detailed description

The secondary objectives of the study are:

Evaluation of the effect of nutritional supplementation with turmeric (MERIVA®) on memory, executive and attention functions, language, neuropsychiatric profile and daily living ability of Subjects with Metabolic Syndrome;
Evaluation of the effect of nutritional supplementation with turmeric (MERIVA®) on the body composition of Subjects with Metabolic Syndrome;
Evaluation of the effect of nutritional supplementation with turmeric (MERIVA®) on the arterial properties of Subjects with Metabolic Syndrome;
Evaluation of the effect of nutritional supplementation with turmeric (MERIVA®) on glucose metabolism and on the lipid and immune structure of Subjects with Metabolic Syndrome;
Evaluation of the influence of gender / gender on the response to nutritional supplementation with turmeric (MERIVA®) in Subjects with Metabolic Syndrome;
Confirmation of the safety profile of nutritional supplementation with turmeric (MERIVA®) in Subjects with Metabolic Syndrome.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2
Model description: This is a double-blind, randomized, single-center clinical trial. Patients enrolled will be randomized in a 1:1 ratio between groups and sexes to receive the test product MERIVA® (Group A) or its correspondent placebo (Group B).

Arm	Type	Receives
Nutritional Supplementation with Test Product	Experimental	Dietary Supplement: MERIVA® TabletsSubjects will receive 1 tablet of MERIVA® in two administrations per day (one in the morning, one in the evening during meals) for a period of 6 months. This treatment corresponds to 1 g / day of experimental product (corresponding to about 200 mg of curcuminoids).
Control Group without Nutritional Supplementation	Placebo comparator	Other: Placebo TabletsSubjects will receive 1 tablet of placebo in two administrations per day (one in the morning, one in the evening during meals) for a period of 6 months.

Who may qualify

Ages: 60 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Male or female subjects.
Subjects aged ≥ 60 years.
Subjects with Metabolic Syndrome diagnosed according to standard criteria:
Subjects who understand the nature of the study and provide their informed consent to participate.
Subjects willing and able to participate in the visits and in the procedures foreseen by the study protocol.

Key exclusion criteria (9 listed)

Subjects with dementia with MMSE <24 test and on therapy with cholinesterase inhibitors or memantine*.
Subjects with serious concomitant internal medical conditions or with neurological pathologies capable of causing cognitive dysfunction.
Subjects with hepato-biliary disorders, including bile duct obstruction, cholangitis, gallstones.
Subjects addicted to alcohol or drugs, or treated with psychotropic drugs at the time of enrollment.
Subjects with known or suspected allergy or hypersensitivity to turmeric or other components of the experimental / placebo product.

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
MERIVA® TabletsThe treatment corresponds to 1 g / day of experimental product (corresponding to about 200 mg of curcuminoids).	Dietary supplement	Nutritional Supplementation with Test Product
Placebo TabletsThe composition of placebo includes the same components of the treatment tablets, except for the active substance.	Other	Control Group without Nutritional Supplementation

Primary outcome

Change from Baseline of Mini-Mental State Examination (MMSE) Test
Time frame: Change from Baseline (T0) to 6 months of treatment (T6) and 12 months of treatment (T12).
Percentage of subjects showing an improvement in performance in Mini-Mental State Examination (MMSE) test in comparison to baseline, defined as an increase of more than 2 points in the test. A difference between the group treated with MERIVA® versus placebo of at least 20% in the proportion of subjects with clinical improvement as defined above is considered clinically relevant. The differences between genders are considered.
Change from Baseline of Montreal Cognitive Assessment (MOCA) Test
Time frame: Change from Baseline (T0) to 6 months of treatment (T6) and 12 months of treatment (T12).
Percentage of subjects showing an improvement in performance in Montreal Cognitive Assessment (MOCA) test in comparison to baseline, defined as an increase of more than 2 points in the test. A difference between the group treated with MERIVA® versus placebo of at least 20% in the proportion of subjects with clinical improvement as defined above is considered clinically relevant. The differences between genders are considered.

14 secondary outcomes

Change from Baseline of Rey's Auditory Verbal Learning Test (RAVLT) Test
Time frame: Change from Baseline (T0) to 6 months of treatment (T6) and 12 months of treatment (T12).
Change from Baseline of Trail Making Test (TMT) Test
Time frame: Change from Baseline (T0) to 6 months of treatment (T6) and 12 months of treatment (T12).
Change from Baseline of Multiple Features Target Cancellation (MFTC) Test
Time frame: Change from Baseline (T0) to 6 months of treatment (T6) and 12 months of treatment (T12).
Change from Baseline of Phonological and Semantic Verbal Fluidity (FVS) Test
Time frame: Change from Baseline (T0) to 6 months of treatment (T6) and 12 months of treatment (T12).
Change from Baseline of Geriatric Depression Scale (GDS) Test
Time frame: Change from Baseline (T0) to 6 months of treatment (T6) and 12 months of treatment (T12).
Change from Baseline of Neuro-Psychiatric Inventory (NPI) Test
Time frame: Change from Baseline (T0) to 6 months of treatment (T6) and 12 months of treatment (T12).
Change from Baseline of Basic Activities of Daily Living (BADL) Test
Time frame: Change from Baseline (T0) to 6 months of treatment (T6) and 12 months of treatment (T12).
Change from Baseline of Instrumental Activities of Daily Living (IADL) Test
Time frame: Change from Baseline (T0) to 6 months of treatment (T6) and 12 months of treatment (T12).
Change from Baseline of Stroop Test - Short Version
Time frame: Change from Baseline (T0) to 6 months of treatment (T6) and 12 months of treatment (T12).
Change from Baseline of Bioelectrical Impedance (BIA) Assessment
Time frame: Change from Baseline (T0) to 6 months of treatment (T6) and 12 months of treatment (T12).
Change from Baseline of Metabolism Parameters measured in Blood
Time frame: Change from Baseline (T0) to 6 months of treatment (T6) and 12 months of treatment (T12).
Change from Baseline of Lipid and Immune Profile measured in Blood
Time frame: Change from Baseline (T0) to 6 months of treatment (T6) and 12 months of treatment (T12).
Change from Baseline of Brain-Derived Neurotrophic Factor (BDNF) and p66Shc Gene Expression measured in Blood
Time frame: Change from Baseline (T0) to 6 months of treatment (T6).
Rate and Characterization of Adverse Events occurred to Subjects
Time frame: Pre-Screening (T-1) / Baseline (T0) / After 3 months of treatment (T3) / After 6 months of treatment (T6) / After 12 months of treatment (T12).

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
Background: PubMed 24605806Petersen RC, Caracciolo B, Brayne C, Gauthier S, Jelic V, Fratiglioni L. Mild cognitive impairment: a concept in evolution. J Intern Med. 2014 Mar;275(3):214-28. doi: 10.1111/joim.12190.
Background: PubMed 21514250McKhann GM, Knopman DS, Chertkow H, Hyman BT, Jack CR Jr, Kawas CH, Klunk WE, Koroshetz WJ, Manly JJ, Mayeux R, Mohs RC, Morris JC, Rossor MN, Scheltens P, Carrillo MC, Thies B, Weintraub S, Phelps CH. The diagnosis of dementia due to Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement. 2011 May;7(3):263-9. doi: 10.1016/j.jalz.2011.03.005. Epub 2011 Apr 21.
Background: PubMed 16556968Mrak RE, Griffin WS. Potential inflammatory biomarkers in Alzheimer's disease. J Alzheimers Dis. 2005 Mar;8(4):369-75. doi: 10.3233/jad-2005-8406.
Background: PubMed 21115952Schrijvers EM, Witteman JC, Sijbrands EJ, Hofman A, Koudstaal PJ, Breteler MM. Insulin metabolism and the risk of Alzheimer disease: the Rotterdam Study. Neurology. 2010 Nov 30;75(22):1982-7. doi: 10.1212/WNL.0b013e3181ffe4f6.
Background: PubMed 20739649Matsuzaki T, Sasaki K, Tanizaki Y, Hata J, Fujimi K, Matsui Y, Sekita A, Suzuki SO, Kanba S, Kiyohara Y, Iwaki T. Insulin resistance is associated with the pathology of Alzheimer disease: the Hisayama study. Neurology. 2010 Aug 31;75(9):764-70. doi: 10.1212/WNL.0b013e3181eee25f. Epub 2010 Aug 25.
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Sponsor company websiteLink provided by the sponsor.
Individual participant dataSharing planned: No

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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.

Andrea Giaccari, Prof. principal investigator

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing MERIVA® Tablets in people with Mild Cognitive Impairment, run by Indena S.p.A at 1 site in Italy.

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 11 inclusion and 9 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: finished, as of the sponsor's last update on 2 Feb 2026. 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 Italy. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change from Baseline of Mini-Mental State Examination (MMSE) Test (time frame: Change from Baseline (T0) to 6 months of treatment (T6) and 12 months of treatment (T12).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04705220, which also lists 12 linked publications.

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 2 Feb 2026.