Clinical Trials Register

Summary
EudraCT Number:	2019-000604-15
Sponsor's Protocol Code Number:	PTC-19-602325
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2020-10-21
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2019-000604-15

A.3

Full title of the trial

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

Studio di fase II, multicentrico, randomizzato, in doppio cieco, controllato con placebo, a gruppi paralleli, volto a valutare l'efficacia e la sicurezza di Zinco Solfato in pazienti con malattia di Alzheimer prodromica

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

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

Studio sul trattamento dei prodromi della malattia Alzheimer con Zinco Solfato.

A.3.2

Name or abbreviated title of the trial where available

ZincAid

A.4.1

Sponsor's protocol code number

PTC-19-602325

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	UNIVERSITÀ DEGLI STUDI "G. D'ANNUNZIO" CHIETI-PESCARA
B.1.3.4	Country	Italy
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Alzheimer's Association (Chicago)
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Dipartimento di Neuroscienze, Imaging e Scienze Cliniche
B.5.2	Functional name of contact point	Unità funzionale
B.5.3	Address:
B.5.3.1	Street Address	Via Luigi Polacchi, 11
B.5.3.2	Town/ city	Chieti Scalo
B.5.3.3	Post code	66100
B.5.3.4	Country	Italy
B.5.4	Telephone number	0871541544
B.5.5	Fax number	999999
B.5.6	E-mail	ssensi@unich.it

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	ZINCO SOLFATO IDI - 200 MG COMPRESSE 30 COMPRESSE
D.2.1.1.2	Name of the Marketing Authorisation holder	IDI FARMACEUTICI S.R.L.
D.2.1.2	Country which granted the Marketing Authorisation	Italy
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Zinco Solfato
D.3.2	Product code	[ZS]
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ZINCO SOLFATO
D.3.9.2	Current sponsor code	ZS
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	135
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Tablet
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Prodromic Alzheimer's disease with evidence of cerebral amyloidosis.

Malattia di Alzheimer prodromica con evidenza di amiloidosi cerebrale.

E.1.1.1

Medical condition in easily understood language

Initial dementia without impairment of social or activities of daily living

Demenza iniziale in assenza di compromissione delle funzioni sociali o delle attività della vita quotidiana

E.1.1.2

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10001896
E.1.2	Term	Alzheimer's disease
E.1.2	System Organ Class	100000004852

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

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.

Valutare la tollerabilità e l'efficacia dello Zinco Solfato sugli ‘outcomes’ cognitivi di soggetti con malattia di Alzheimer prodromica e la progressione dei deficit cognitivi

E.2.2

Secondary objectives of the trial

Validate the non-ceruloplasminic copper as bio-marker to identify a specific sub-group of individuals with prodromic Alzheimer's disease.

Convalidare i livelli di rame non-ceruloplasminico come biomarker per identificare un sottogruppo specifico di individui con malattia di Alzheimer prodromica

E.2.3

Trial contains a sub-study

E.3

Principal 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 .

1. 50-80 anni. Se donne, in menopausa da almeno 2 anni.
2. Concentrazione sierica di nCp-Cu> 1,6 µmol / L;
3. Presenza stabile di un componente famigliare per supporto informativo, che è in contatto con il soggetto per un periodo di tempo sufficiente a valutarlo;
4. Rilascio del consenso informato scritto prima della partecipazione allo studio;
5. Capacità di piena conformità ai requisiti del protocollo (es .: assunzione del medicinale per os, ecc.);
6. RM cerebrale eseguita nei 12 mesi precedenti o alla visita di screening;
7. Evidenza di amiloidosi cerebrale mediante scansione con Florbetapir (18F) -PET entro 12 mesi o positiva per biomarcatori CSF di AD;
8. Criteri diagnostici per MCI.

E.4

Principal 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

1. Malattie e disabilità concomitanti, in corso o ricorrenti, gravi o instabili che possono interferire con il metabolismo del Cu e con la valutazione dei risultati primari e secondari o possono influenzare la valutazione dello stato clinico o mentale del soggetto o mettere il soggetto a rischio speciale;
2. Malattie cardiovascolari gravi o instabili concomitanti;
3. Disturbo neurodegenerativo primario concomitante oltre a MCI (Mild Cognitive Impairment), o disturbi neurologici o psichiatrici di qualsiasi eziologia;
4. Anemia clinicamente significativa alla visita di screening.
5. È consentita l'interruzione dei trattamenti precedenti prima di 3 mesi dalla visita di screening

E.5 End points

E.5.1

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.

Due scale cognitive derivate da ADAS-Cog, ovvero la scala cognitiva composita 2 (CC2) e la scala rivisitata ADAS-Cog, che sono misure di esito convalidate specificamente per studi clinici su pazienti con Mental Cognitive Impairment (MCI)

E.5.1.1

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)

Visit 1, Week 1 (Visita basale)
Visit 5, week 24
Visit 7, week 52
Visit 11, week 104 (Visita finale)

E.5.2

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)

E.5.2.1

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)

Visit 1, Week 1 (Visita basale)
Visit 5, week 24
Visit 7, week 52
Visit 11, week 104 (Visita finale)

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

E.6.5

Efficacy

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

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:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

215

F.4.2

For a multinational trial

F.4.2.1

In the EEA

215

F.4.2.2

In the whole clinical trial

215

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

Not applicable

Non applicabile

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2020-07-10

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-10-29

P. End of Trial
P.	End of Trial Status	Ongoing

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