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Clinical Trials/EUCTR2016-003669-24-IT
EUCTR2016-003669-24-IT
Active, not recruiting
Phase 1

Amyloid PET imaging study for the diagnosis of Alzheimer's disease in the preclinical/predementia phase - Non Disponibile

OSPEDALE SAN RAFFAELE0 sites180 target enrollmentOctober 1, 2021
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Conditionsmemory complaint, mild cognitive impairment, Alzheimer's Disease in predrmentia/prodromal disease phasesMedDRA version: 22.1Level: LLTClassification code 10050727Term: RI scanSystem Organ Class: 100000004848Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
DrugsNEURACEQ - 300 MBQ/ML - SOLUZIONE INIETTABILE - USO ENDOVENOSO - FLACONCINO (VETRO) - 1 FLACONCINO MONODOSE

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
memory complaint, mild cognitive impairment, Alzheimer's Disease in predrmentia/prodromal disease phases
Sponsor
OSPEDALE SAN RAFFAELE
Enrollment
180
Status
Active, not recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 1, 2021
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
OSPEDALE SAN RAFFAELE

Eligibility Criteria

Inclusion Criteria

  • •diagnosis of memory complaint, mild cognitive impairment or Alzheimer disease; age \> 18 years old
  • •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 80
  • •F.1\.3 Elderly (\>\=65 years) yes
  • •F.1\.3\.1 Number of subjects for this age range 100

Exclusion Criteria

  • •presence of other neurological and clinical condition responsible of cognitive disorders; liver and kidney failure; pregnancy and breastfeeding; fertile women do not using contraceptive drugs; hypersensitivity to active principle and excipients (ascorbic acid; anidre ethanol; macrogol 400; ascorbic sodium; water for injections)

Outcomes

Primary Outcomes

Not specified

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