Multicentre, randomized, double-blind, placebo-controlled, parallel-group Phase II study aimed at evaluating the efficacy and safety of “Zinco Solfato” in Mild Cognitive Impairment due to Alzheimer’s disease

INTERVENTION: Trade Name: ZINCO SOLFATO IDI ‐ 200 MG COMPRESSE 30 COMPRESSE Product Name: Zinco Solfato Product Code: [ZS] Pharmaceutical Form: Tablet INN or Proposed INN: ZINCO SOLFATO Current Sponsor code: ZS Concentration unit: mg milligram(s) Concentration type: up to Concentration number: 135‐ Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use CONDITION: Prodromic Alzheimer's disease with evidence of cerebral amyloidosis. ; MedDRA version: 20.0 Level: LLT Classification code 10001896 Term: Alzheimer's disease System Organ Class: 100000004852 Therapeutic area: Diseases [C] ‐ Nervous System Diseases [C10] PRIMARY OUTCOME: Main Objective: Assess the efficacy and tolerability of Zinc Sulphate on the cognitive outcomes of subjects with prodromic Alzheimer's disease and the progression of cognitive deficits. Primary end point(s): Two cognitive scales derived from ADAS‐Cog, namely the Cognitive Composite 2 scale (CC2) and ADAS‐Cog revisited scale, which are an outcome measures validated specifically for clinical trials on MCI patients. Secondary Objective: Validate the non‐ceruloplasminic copper as bio‐marker to identify a specific sub‐group of individuals with prodromic Alzheimer's disease. Timepoint(s) of evaluation of this end point: Visit 1, Week 1 (Baseline); Visit 5, week 24; Visit 7, week 52; Visit 11, week 104 (Completion) SECONDARY OUTCOME: Secondary end point(s): Repeatable Battery for the Assessment of Neuropsychological Status (RBANS); Mini‐Mental State Examination (MMSE); Geriatric Depression Scale (GDS); Neuropsychiatric Inventory (NPI); Clinical Dementia Rating scale (CDR); Resource Utilization in Dementia (RUD) Timepoint(s) of evaluation of this end point: Visit 1, Week 1 (Baseline); Visit 5, week 24; Visit 7, week 52; Visit 11, week 104 (Completion) INCLUSION CRITERIA: 1. 50‐80 years old. If Women, in menopause since at least 2 years. 2. nCp‐Cu serum concentration > 1.6 µmol/L; 3. Stable presence of an informant family member, who is in contact with the subject for a period of time sufficient to assess him/her; 4. Release of written informed consent prior to participation in the study; 5. Capacity of full compliance with the protocol requirements (i.e.: assumption of the medicine per os, etc.); 6. Brain MRI performed within 12 months preceding or at the Screening Visit; 7. evidence of cerebral amyloidosis by scanning with Florbetapir (18F)‐PET within 12 months or positive for CSF biomarkers of AD; 8. Diagnostic criteria for MCI . Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 157 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 58