Cognitive DysfunctionBLAtwelveNCT03825042

Effect of an Antioxidants Mix on Cognitive Performance and Well Being: The Bacopa, Licopene, Astaxantina, Vitamin B12

A study testing A mix of bioactive natural compounds in people with Cognitive Dysfunction, run by A. Menarini Industrie Farmaceutiche Riunite S.r.l. 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

Nine-weeks double-blind, randomized, placebo-controlled, parallel-arm superiority study. The aim of this study is to evaluate the influence of a mix of four bioactive compounds - bacopa, lycopene, astaxanthin and vitamin B12 - on cognitive performance, mood state and well-being in subjects aged ≥ 60 years with no… Read more about this study

Who is it for?: Ages 60 years and older
Conditions the study is for: Cognitive Dysfunction
What is being tested?: A mix of bioactive natural compounds
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 80 participants
Where: 1 siteItaly
Study dates: 23 Jan 2018to 29 Oct 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Subjects aged ≥60 years.
Subjects who provide written Informed Consent to the study.

Who cannot join

Subjects with cognitive dysfunctions or clinically significant coexisting medical conditions (cardiovascular disease, cerebrovascular events, overt dementia defined by MMSE <27 or other neurological disorders, thyroid disorders, or inflammatory diseases)
Subjects with a score on the Geriatric Depression Scale (GDS) >11 in order to avoid confounding due to the influence of concomitant depression on the performance on cognitive tests
Current smokers
Habitual users of antioxidant supplements (including vitamins C and E)
Habitual consumers of chocolate or other cocoa products (daily consumption of any amount)
Subjects under treatments with medications known to have antioxidant properties (including statins and glitazones) or to interfere with cognitive functions (including benzodiazepines and antidepressants)
Subjects with hypersensitivity to any component of the study medications
Subjects who are participating in or having participated in another clinical trial within the previous three months.

Trial locations and contacts

1 site in 1 country.

Italy1 site

U.O.C. Geriatria e Lungodegenza - P.O. SS Filippo e Nicola di Avezzano
Avezzano, L'Aquila, 67051

Other trials in Italy

About this study

Nine-weeks double-blind, randomized, placebo-controlled, parallel-arm superiority study.

The aim of this study is to evaluate the influence of a mix of four bioactive compounds - bacopa, lycopene, astaxanthin and vitamin B12 - on cognitive performance, mood state and well-being in subjects aged ≥ 60 years with no evidence of cognitive dysfunction.

The primary objective of the study is to evaluate the changes in Trial Making Test (TMT) scores from baseline (V2) to 8 weeks of treatment (V4), analyzed in the following hierarchical order: TMT-B, TMT-A and TMT B-A.

Secondary objectives of this study are to evaluate changes from baseline (V2) to 8 weeks of treatment (V4) in Verbal Fluency Test (VFT) score, Montreal Cognitive Assessment (MoCA) score, Mini Mental State Examination (MMSE) score, Rey Auditory Verbal Learning Test (AVLT), psychological well-being as assessed by General Health Questionnaire (GHQ-12), mood states as assessed by the Profile of Mood Stated (POMS), sexual satisfaction as evaluated by the New Sexual Satisfaction Scale (NSSS).

Changes of metabolic parameters from baseline (V2) to 4 weeks of treatment (V3) and from baseline (V2) to 8 weeks of treatment (V4) will be also evaluated as secondary objectives (glucose, insulin, Homeostatic Model Assessment for Insulin Resistance (HOMA-IR), total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, uric acid).

Changes of plasma markers of oxidative stress from baseline (V2) to 4 weeks of treatment (V3) and from baseline (V2) to 8 weeks of treatment (V4) will be evaluated as secondary objectives (8-iso-Prostaglandin F2alpha, Plasma malondialdehyde).

Finally the safety and tolerability of the study product will be assessed.

Read the detailed description

The study has been conducted in 1 Italian clinical site and involved 80 subjects.

Subjects will be randomly allocated to one of the following groups:

Group I: mix of the four bioactive compounds (bacopa, lycopene, astaxanthin and vitamin B12), once a day for 8 weeks per os;
Group II: placebo, once a day for 8 weeks per os.

The study is double blind. Neither the study staff at clinical sites (Investigators, nurses, pharmacist) nor the subject was aware of the treatment assigned.

Each participant attended 4 visits over a total period of about 9 weeks.

Conditions: Cognitive Dysfunction
Being tested: A mix of bioactive natural compounds, Placebo
Medical subject headings: Cognitive Dysfunction

What participants receive

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

A mix of bioactive natural compoundsDietary supplement
A mix of bacopa, lycopene, astaxanthin and vitamin B12 in oral tablets
PlaceboDietary supplement
Inactive compound in oral tablets

Study groups in NCT03825042
Study group	Role	What they receive
Food supplement	Experimental	A mix of bacopa, lycopene, astaxanthin and vitamin B12 Dosage form: tablets Dosage: 1 tablet/die Duration: 8 weeks Receives: Dietary Supplement: A mix of bioactive natural compounds
Placebo	Placebo comparator	Inactive compound Dosage form: tablets Dosage: 1 tablet/die Duration: 8 weeks Receives: Dietary Supplement: Placebo

What is being measured

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

Change in Trail Making Test (TMT) B Between Baseline and End of Treatment
Change in Trail Making Test (TMT) B scores from baseline (V2) to 8 weeks of treatment (V4).
The reduction in the number of seconds the patients take to make the test after the study treatment means an improvement in cognitive functions.
Measured: 8 weeks - from baseline to end of study
Change Trail Making Test (TMT) A Between Baseline and End of Treatment
Change in Trail Making Test (TMT) A scores from baseline (V2) to 8 weeks of treatment (V4).
The reduction in the number of seconds the patients take to make the test after the study treatment means an improvement in cognitive functions.
Measured: 8 weeks - from baseline to end of study
Change in Trail Making Test (TMT) B - Trail Making Test (TMT) A Between Baseline and End of Treatment
Change in Trail Making Test (TMT) B score minus Trail Making Test (TMT) A score from baseline (V2) to 8 weeks of treatment (V4).
The reduction in the number of seconds the patients take to make the test after the study treatment means an improvement in cognitive functions.
Measured: 8 weeks - from baseline to end of study

Timeline

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

23 Jan 201829 Oct 2018

First posted31 Jan 2019
Study start23 Jan 2018
Primary completion29 Oct 2018
Study completion29 Oct 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Cognitive DysfunctionStudies 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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: 9-weeks double-blind, randomized, placebo-controlled, parallel-arm superiority study
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03825042
Sponsor's protocol ID: MEIF/17/BAC-COG/001
Acronym: BLAtwelve
Status last verified: Feb 2019
First submitted: 30 Jan 2019
Last updated: 27 Jul 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

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?

See locations

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All Cognitive Dysfunction trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of an Antioxidants Mix on Cognitive Performance and Well Being: The Bacopa, Licopene, Astaxantina, Vitamin B12
ClinicalTrials.gov ID: NCT03825042
Acronym / sponsor ID: BLAtwelve / MEIF/17/BAC-COG/001
Conditions: Cognitive Dysfunction
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: A. Menarini Industrie Farmaceutiche Riunite S.r.l.Industry (pharma, biotech, devices)
Study start: 23 Jan 2018 (actual)
Primary completion: 29 Oct 2018 (actual)
Study completion: 29 Oct 2018 (actual)
First posted: 31 Jan 2019 (actual)
Results: Posted 27 Jul 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Nine-weeks double-blind, randomized, placebo-controlled, parallel-arm superiority study.

Finally the safety and tolerability of the study product will be assessed.

Detailed description

The study has been conducted in 1 Italian clinical site and involved 80 subjects.

Subjects will be randomly allocated to one of the following groups:

Group I: mix of the four bioactive compounds (bacopa, lycopene, astaxanthin and vitamin B12), once a day for 8 weeks per os;
Group II: placebo, once a day for 8 weeks per os.

The study is double blind. Neither the study staff at clinical sites (Investigators, nurses, pharmacist) nor the subject was aware of the treatment assigned.

Each participant attended 4 visits over a total period of about 9 weeks.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: 9-weeks double-blind, randomized, placebo-controlled, parallel-arm superiority study

Arm	Type	Receives
Food supplement	Experimental	Dietary Supplement: A mix of bioactive natural compoundsA mix of bacopa, lycopene, astaxanthin and vitamin B12 Dosage form: tablets Dosage: 1 tablet/die Duration: 8 weeks
Placebo	Placebo comparator	Dietary Supplement: PlaceboInactive compound Dosage form: tablets Dosage: 1 tablet/die Duration: 8 weeks

Who may qualify

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

Key inclusion criteria (2 listed)

Subjects aged ≥60 years.
Subjects who provide written Informed Consent to the study.

Key exclusion criteria (8 listed)

Subjects with cognitive dysfunctions or clinically significant coexisting medical conditions (cardiovascular disease, cerebrovascular events, overt dementia defined by MMSE <27 or other neurological disorders, thyroid disorders, or inflammatory diseases)
Subjects with a score on the Geriatric Depression Scale (GDS) >11 in order to avoid confounding due to the influence of concomitant depression on the performance on cognitive tests
Current smokers
Habitual users of antioxidant supplements (including vitamins C and E)
Habitual consumers of chocolate or other cocoa products (daily consumption of any amount)

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
A mix of bioactive natural compoundsA mix of bacopa, lycopene, astaxanthin and vitamin B12 in oral tablets	Dietary supplement	Food supplement
PlaceboInactive compound in oral tablets	Dietary supplement	Placebo

Primary outcome

Change in Trail Making Test (TMT) B Between Baseline and End of Treatment
Time frame: 8 weeks - from baseline to end of study
Change in Trail Making Test (TMT) B scores from baseline (V2) to 8 weeks of treatment (V4). The reduction in the number of seconds the patients take to make the test after the study treatment means an improvement in cognitive functions.
Change Trail Making Test (TMT) A Between Baseline and End of Treatment
Time frame: 8 weeks - from baseline to end of study
Change in Trail Making Test (TMT) A scores from baseline (V2) to 8 weeks of treatment (V4). The reduction in the number of seconds the patients take to make the test after the study treatment means an improvement in cognitive functions.
Change in Trail Making Test (TMT) B - Trail Making Test (TMT) A Between Baseline and End of Treatment
Time frame: 8 weeks - from baseline to end of study
Change in Trail Making Test (TMT) B score minus Trail Making Test (TMT) A score from baseline (V2) to 8 weeks of treatment (V4). The reduction in the number of seconds the patients take to make the test after the study treatment means an improvement in cognitive functions.

Results and safety

Results posted to the registry on 27 Jul 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Food Supplement	40	38
Placebo	40	40

Primary outcome: Change in Trail Making Test (TMT) B Between Baseline and End of Treatment

Time frame: 8 weeks - from baseline to end of study. Mean (Standard Deviation). Unit: seconds

Measure	Food Supplement n = 38	Placebo n = 40
Value	-17.63 (18.93)	3.46 (13.08)

Food Supplement vs Placebo: Mean Difference (Final Values): -21.01 (95% CI -26.80 to -15.20), p = 0.0000, ANCOVA

Population analysed: Intention To Treat

Primary outcome: Change Trail Making Test (TMT) A Between Baseline and End of Treatment

Time frame: 8 weeks - from baseline to end of study. Mean (Standard Deviation). Unit: seconds

Measure	Food Supplement n = 38	Placebo n = 40
Value	-6.86 (10.00)	-0.37 (5.31)

Food Supplement: Mean Difference (Final Values): -6.08 (95% CI -8.45 to -3.61), p = 0.0000, ANCOVA

Population analysed: Intention To Treat

Primary outcome: Change in Trail Making Test (TMT) B - Trail Making Test (TMT) A Between Baseline and End of Treatment

Time frame: 8 weeks - from baseline to end of study. Mean (Standard Deviation). Unit: seconds

Measure	Food Supplement n = 38	Placebo n = 40
Value	-10.46 (16.62)	3.84 (11.65)

Food Supplement vs Placebo: Mean Difference (Final Values): -14.56 (95% CI -20.02 to -9.11), p = 0.0000, ANCOVA

Population analysed: Intention To Treat

Adverse events

Time frame: 8 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Food Supplement	1 of 40 (2.5%)	1 of 40 (2.5%)	0 of 40
Placebo	0 of 40 (0%)	0 of 40 (0%)	0 of 40

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Giovambattista GD Desideri principal investigator

U.O.C. Geriatria e Lungodegenza - P.O. SS Filippo e Nicola di Avezzano

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

Questions about this trial

What is this clinical trial studying?

A study testing A mix of bioactive natural compounds in people with Cognitive Dysfunction, run by A. Menarini Industrie Farmaceutiche Riunite S.r.l. 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 2 inclusion and 8 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 27 Jul 2020. 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?

Yes. Results are posted in the registry (first posted 27 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 in Trail Making Test (TMT) B Between Baseline and End of Treatment (time frame: 8 weeks - from baseline to end of study). The study lists 3 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 NCT03825042.

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 27 Jul 2020.