Amyloid pathology in cognitively normal elderly subjects (PreclinAD)

Recruitment & Eligibility

Status: Authorised, recruitment pending

Sex: Not specified

Target Recruitment: 204

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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		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

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (1): Amsterdam UMC Stichting
🇳🇱
Amsterdam, Netherlands
Amsterdam UMC Stichting
🇳🇱Amsterdam, Netherlands
Anouk den Braber
Site contact
0031623048053
ctis@amsterdamumc.nl