UnknownPhase 1/2

Clinical Trial of a Low Protein Diet in Patients With Cognitive Impairment

Italy40 participantsStarted 2019-11-01

Plain-language summary

The wide-acting effects of Fasting-Mimicking Diets (FMDs) on metabolic, inflammatory and regenerative pathways leading to reduced pathology or risk factors for various diseases in mice and humans, has the potential to be effective against Alzheimer's disease (AD). It is proposed to conduct a randomized clinical trial of twelve monthly cycles of the ProlonADTM diet (by L-Nutra) vs. placebo diet in patients with aMCI or mild AD (MMSE 18-23). The primary endpoint of the study will be the feasibility and safety of the twelve cycles of ProlonADTM.

Who can participate

Age range

55 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age 55-80; * Presence of aMCI or initial AD (MMSE 18-23); * Normal organ function (liver and kidney); * BMI not less than 20 kg/m2; * Bioimpedance phase angle (PA) \> 5 °; * Adherence to informed consent Exclusion Criteria: * Age\> 80 years * Diabetes mellitus; * Organ impairment (liver, kidney); * Food allergies to the components of ProlonADTM; * Patients on therapy with vitamin K antagonist anticoagulants; * PA \<5 °; * Patients who live alone or are not adequately supported by the family context; * Other experimental therapies in progress.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of Treatment-Emergent Adverse Events

Timeframe: 12 months

Percentage of patients able to achieve the designated diet regimen

Timeframe: 12 months

Trial details

NCT IDNCT05480358

SponsorUniversity of Genova

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-08

View on ClinicalTrials.gov More Mild Cognitive Impairment trials