Study on the treatment of the mild congnitive impairment due to Alzheimer's disease with Zinc Sulphate

Phase 1

• Conditions: Prodromic Alzheimer's disease with evidence of cerebral amyloidosis.; MedDRA version: 20.0Level: LLTClassification code 10001896Term: Alzheimer's diseaseSystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2019-000604-15-IT
• Lead Sponsor: IVERSITÀ DEGLI STUDI G. D'ANNUNZIO CHIETI-PESCARA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-21
• Last Update Posted: 11 January 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 215

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)<br>Visit 5, week 24<br>Visit 7, week 52<br>Visit 11, week 104 (Completion);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.

Secondary Outcome Measures

Name	Time	Method
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)<br>Visit 5, week 24<br>Visit 7, week 52<br>Visit 11, week 104 (Completion)