Amyloid pathology in cognitively normal elderly subjects (PreclinAD)

Amsterdam UMC Stichting1 site in 1 country204 target enrollmentNovember 29, 2024

DrugsFLUTEMETAMOL F-18 Flutemetamol F 18 VIZAMYL 400 MBq/mL solution for injection

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Not specified
Sponsor: Amsterdam UMC Stichting
Enrollment: 204
Locations: 1
Primary Endpoint: 1.To identify clinical markers and biomarkers for amyloid pathology in cognitively normal subjects; 2.To identify risk factors for (change in) amyloid pathology in cognitively normal subjects, 3.To identify prognostic markers for cognitive decline in cognitively normal subjects with amyloid pathology
Status: Not yet recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

To validate known and to discover novel diagnostic markers and risk factors for amyloid pathology in cognitively normal subjects and to validate known and to discover novel predictors for cognitive decline in cognitively normal subjects with amyloid pathology.

Registry

euclinicaltrials.eu

Start Date

November 29, 2024

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Investigators

Sponsor

Amsterdam UMC Stichting

Responsible Party

Principal Investigator

Anouk den Braber

Scientific

Amsterdam UMC Stichting

Eligibility Criteria

Inclusion Criteria

•In order to be eligible to participate in this study, a participant must meet all of the following criteria:  Age 60-100 years  Telephone Interview for Cognitive Status modified (TICS-m) >22 (de Jager, Budge et al. 2003)  Geriatric Depression Scale (GDS) (15 item) <11(Yesavage, Brink et al. 1982)  Consortium to Establish a Registry for Alzheimer’s Disease (CERAD) 10 word list immediate and delayed recall (> -1.5 SD of age adjusted normative data) (Morris, Heyman et al. 1989)  Clinical Dementia Rating (CDR) scale of 0 with a score on the memory sub domain of 0 (Morris 1993)

Exclusion Criteria

•A potential participant who meets any of the following criteria will be excluded from participation in this study:  Clinical diagnosis of mild cognitive impairment or probable AD  Severe head trauma, with loss of consciousness  Brain tumour (past, present)  Schizophrenia, bipolar disorders, or recurrent psychotic disorders  Stroke resulting in physical impairment  Neurodegenerative disorders (e.g. Huntington disease, cortical basal degeneration, multiple system atrophy, Creutzfeldt-Jacob disease, primary progressive aphasia, Parkinson’s disease)  Epilepsy, currently using antiepileptic drugs (AEDs)  Brain infection (e.g. herpes simplex encephalitis)  Cancer with terminal life expectancy  Known B12 vitamin deficiency without treatment  Uncontrolled diabetes mellitus  Known thyroid disease without treatment  History of recreational drug use  Alcohol consumption: >35 units per week  Physical morbidity or illness which will not permit attendance at visit sessions  Contraindication for MRI (e.g. metal implants, pacemaker etc.)  Medications that may impair cognition, at the discretion of the investigator, e.g.: o High dose benzodiazepine o Lithium carbonate o Antipsychotics including atypical agents o High dose antidepressants o Parkinson’s disease medicines

Outcomes

Primary Outcomes

1.To identify clinical markers and biomarkers for amyloid pathology in cognitively normal subjects; 2.To identify risk factors for (change in) amyloid pathology in cognitively normal subjects, 3.To identify prognostic markers for cognitive decline in cognitively normal subjects with amyloid pathology