Amyloid pathology in cognitively normal elderly subjects (PreclinAD)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Amsterdam UMC Stichting

Participant type

Healthy volunteers

Age range

65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Trial duration

29 Nov 2024 → ongoing

Decision date (initial)

2024-11-29

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-518559-41-01

EudraCT number

2014-000219-15

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others

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.

Conditions and MedDRA coding

Healthy controls (investigating preclinical Alzheimer's Disease)

Regulatory references

Plan to share IPD

Yes

IPD plan description

After completion of recruitment and publication of the main analyses proposed in the application, pseudonymized data will be available for bona fide researchers through the AUMC, where third parties can send a data access request proposal for data-sharing to the PI of the study. Data sharing will be performed under a data transfer agreement (DTA). The final format of the dataset to be shared will be an encrypted csv file with the main outcomes of the study for each participant.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. 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 1

1. 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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Amsterdam UMC Stichting

Sponsor organisation

Amsterdam UMC Stichting

Address

De Boelelaan 1117

City

Amsterdam

Postcode

1081 HV

Country

Netherlands

Scientific contact point

Organisation

Amsterdam UMC Stichting

Contact name

Anouk den Braber

Public contact point

Organisation

Amsterdam UMC Stichting

Contact name

Anouk den Braber

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 5 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications