Study of the positron emission tomography (PET) tracer for tau 18F-PI-2620 in individuals with Down syndrome

Phase 1

• Conditions: Taupathies; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2019-004634-41-ES
• Lead Sponsor: Institut de Recerca HSCSP

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-04
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Criteria of control subjects:
- Men and women with age> 35 years.
- Absence of cognitive complaints.
- Normal neuropsychological examination with MMSE scores between 24 and 30, absence of subjective memory complaints or objective memory deficit (measured with the Free and Cued Selective Reminding Test - FCSRT- (Grober, Buschke et al. 1988)) with a scalar score equal to or greater than 8 and a clinical dementia rating scale (CDR) score of 0 (Morris 1993).
- Understand and accept the study procedures and sign an informed consent (guardian and / or patient).

Inclusion criteria for participants with DS:
- Men and women diagnosed with DS> 35 years.
- Intellectual quotient> 34 (equivalent to mild and moderate mental retardation according to ICD-10 criteria).
- Existence of reliable informant.
- Participants / legal guardians who sign the IC for inclusion in the study.
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) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Not meeting the inclusion criteria.
- Severe depression (Geriatric scale score Scale depression> 20).
- History of stroke, Hachinski score> 4 or previous neurological or psychiatric illness.
- Confirmed pregnancy or possibility of pregnancy at the time of inclusion in the study.

Study & Design

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