Prodromic Alzheimers disease with evidence of cerebral amyloidosis. MedDRA version: 20.0 Level: LLT Classification code 10001896 Term: Alzheimers disease System Organ Class: 100000004852
Conditions
Interventions
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
Con
Sponsors
UNIVERSITÀ DEGLI STUDI "G. D'ANNUNZIO" CHIETI-PESCARA
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: 1. Concomitant, in progress, or recurrent, severe, or unstable diseases and disabilities that may interfere with Cu metabolism, and with primary and secondary outcome evaluation, or may bias the assessment of the clinical or mental status of the subject or put the subject at special risk; 2. Concomitant severe or unstable cardiovascular diseases; 3. Concomitant primary neurodegenerative disorder besides MCI, or neurological or psychiatric disorders of any etiology; 4. Clinically significant anemia at the Screening Visit. 5. Prior treatments discontinuation before 3 month from the Screening Visit are allowed
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.;Secondary Objective: Validate the non-ceruloplasminic copper as bio-marker to identify a specific sub-group of individuals with prodromic Alzheimer's disease.;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.;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
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Italy
Contacts
Public ContactUnità funzionale
Dipartimento di Neuroscienze, Imaging e Scienze Cliniche
Outcome results
None listed