Mild Cognitive Impairment Clinical Trial
Official title:
Phase I/II Randomized Clinical Trial of a Low Protein Diet in Patients With Cognitive Impairment
Verified date | July 2022 |
Source | University of Genova |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | August 2023 |
Est. primary completion date | August 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 55 Years to 80 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Italy | Alessio Nencioni | Genoa | GE |
Italy | Ospedale Policlinico San Martino | Genova | |
Italy | Azienda Ospedaliera di Perugia | Perugia |
Lead Sponsor | Collaborator |
---|---|
University of Genova |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of Treatment-Emergent Adverse Events | Safety of FMD in terms of percentage of patients experiencing adverse events and/or worsening of nutritional status.
To obtain clinical data on safety of the FMD in MCI or AD patients as assessed by percentage of patients (%) experiencing > grade 3 adverse events and/or a significant decrease in their lean body mass (kg) and/or with a reduction of phase angle <5° assessed with bio-impedance measurements. |
12 months | |
Primary | Percentage of patients able to achieve the designated diet regimen | Feasibility of FMD in terms of percentage of patients able to complete the diet regimen To evaluate the feasibility of the FMD in MCI and AD patients as assessed by the percentage of patients (%) able to achieve the designated diet regimen. | 12 months | |
Secondary | Efficacy of the FMD in terms of conversion rate to AD | Efficacy of the FMD in terms of coversion rate to AD will be assessed with the conversion rate (%) from AD to aMCI | 12 months | |
Secondary | Efficacy of the FMD in terms of functional state | Efficacy of the FMD in terms of functional will be assessed with Barthel Index (BI) from 0 as the worse score and 100 as the best score. | 12 months | |
Secondary | Efficacy of the FMD in terms of emotional state | Efficacy of the FMD in terms of emotional state will be assessed with the Center for Epidemiologic Studies Depression Scale Revised (CESD-R) with 0 as the best score and 80 as the worse score. | 12 months | |
Secondary | Efficacy of the FMD in terms of nutritional state | Efficacy of the FMD in terms of nutritional state will be assessed with phase angle with bioimpedance (°) | 12 months | |
Secondary | Efficacy of the FMD in terms of caregiver stress' level | Caregiver stress will assessed through Caregiver Burden Inventory (CBI) with 0 as the best score and 96 as the worse score | 12 months | |
Secondary | Efficacy of the FMD in terms of quality of life | Efficacy of the FMD in terms of quality of life of patients with Quality of Life AD (QLQ-AD) with 13 as the worse score and 52 as the best score. | 12 months | |
Secondary | Efficacy of the FMD in terms of prevention of Frailty | Efficacy of the FMD in terms of prevention of Frailty with 40-item Rockwood frailty index (FI) with 0 as the best score and 1 as the worse score. | 12 months | |
Secondary | Efficacy of the FMD in terms of alzheimer and inflammatory biomarkers | We will assess the inflammatory markers, oxidative stress markers, neuronal damage markers (Neurofilament Light, NfL), quantification of circulating stem cells, cell aging markers (eg evaluation of the telomerase activity of lymphocytes) | 12 months | |
Secondary | Efficacy of the FMD in terms of episodic memory | Efficacy of the FMD in terms of episodic memory will evaluated with Free and Cued Selective Reminding Test (FCRST) with a range from 0 as worse score to 36 as best score. | 12 months | |
Secondary | Efficacy of the FMD in terms of general cognitive status | Efficacy of the FMD in terms of general cognitive status with mini-mental state examination (MMSE) with 0 as worse score and 30 as the best score. | 12 months |
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