A study evaluating the diagnostic accuracy of [18F]-AV-1451 PET to detect and distinguish neurodegenerative disorders characterized by cerebral accumulation of the protein tau

Phase 1

Conditions: eurodegenerative disorders with Tau-pathology
including Alzheimer's disease, progressive supranuclear palsy, frontotemporal dementia, corticobasal degeneration and important differential diagnostic conditions.
MedDRA version: 17.0Level: HLTClassification code 10001897Term: Alzheimer's disease (incl subtypes)System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 17.0Level: PTClassification code 10053643Term: Neurodegenerative disorderSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 17.0Level: LLTClassification code 10009846Term: Cognitive impairmentSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 17.0Level: LLTClassification code 10001896Term: Alzheimer's diseaseSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 17.0Level: LLTClassification code 10012285Term: Dementia due to Pick's diseaseSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 17.0Level: PTClassification code 10012267Term: DementiaSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 17.0Level: PTClassification code 10067889Term: Dementia with Lewy bodiesSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 17.0Level: PTClassification code 10036813Term: Progressive supranuclear palsySystem Organ Class: 10029205 - Nervous system disorders

Registration Number: EUCTR2014-000422-38-SE

Lead Sponsor: Skåne University Hospital, Region Skåne

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 590

Inclusion Criteria

The healthy controls should fulfil the following criteria i) at least 60 years of age ii) no cognitive symptoms, iii) MMSE score 28-30, iv) do not fulfil the criteria of mild cognitive impairment or dementia; v) no significant neurological or psychiatric disorder.

The patients with mild cognitive symptoms should fulfil the following criteria: i) at least 60 years of age ii) mild cognitive symptoms, iii) MMSE score 24-30, iv) do not fulfil the criteria of dementia.

The patients clinically diagnosed with a tauopathy” will be at least 50 years of age and they should fulfil the current clinical criteria of AD, FTD, PSP, CBD, PD, PDD, DLB, MSA or VaD.

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 140
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 450

Exclusion Criteria

The exclusion criteria of the present study are:
- History of alcohol or substance abuse or dependence within the last five years.
- Current major depressive disorder.
- History of schizophrenia or other recurrent psychotic disorder.
- Diseases that will make study participation difficult, such as metastatic cancer disease, severe renal or hepatic impairment or significant infectious disease.
- Have received or participated in a trial with investigational medications in the past 30 days.