Non-expensive and Widely Available Tests as Diagnostic To... | NCT01642420

Studies
Non-expensive and Widely Available Tests as Diagnostic Tools in Dementia and Their Ability to Predict Disease Progression

NCT01642420

Sponsor

Zealand University Hospital

Status

Unknown status

Last Update Posted

Sep 13, 2012Estimated

Enrollment

115Estimated

Phase

Not provided

Conditions

Alzheimers Disease
Mild Cognitive Impairment

Interventions

Not provided

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2012

Primary Completion Date

Feb 2017Estimated

Completion Date

Feb 2017Estimated

First Submitted Date

Apr 13, 2012

First Submission Date that Met QC Criteria

Jul 16, 2012

First Posted Date

Jul 17, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 12, 2012

Last Update Posted Date

Sep 13, 2012Estimated

Name	Class
Rigshospitalet, Denmark	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Alzheimers disease (AD) is the most common course of cognitive decline and thereby the course of more than half of all cases of dementia. A proper AD diagnosis is rested on a number of examinations and tests, which combined can make AD diagnosis likely. But no single test or examination can unambiguous determine whether the patient has AD or not. Comparatively no examination or test can with accuracy predict whether a healthy person or a person with only mild cognitive (MCI)impairment in time will evolve AD.

Quantitative Electroencephalography (qEEG), cerebrospinal fluid (CSF) biomarkers, linear CT analyses and Timed Up and Go - Dual Task (TUG-DT) are relatively inexpensive and and widely available diagnostic methods, which have the potential to diagnose AD at an early stage in a reliable accurate way. But they also have the potential to predict which patients diagnosed with MCI have particular risk of developing dementia.

The purpose of the study is to investigate the relations between qEEG, CSF biomarkers, CT analyses and TUG-DT outcome and clinical features in healthy persons as well as patients with MCI and AD Furthermore to investigate whether qEEG or CSF biomarkers can predict which patients with MCI will in time evolve AD.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

115Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mild cognitive impairment		Patients diagnosed with mild cognitive impairment
Alzheimers disease		Patients diagnosed with mild Alzheimers disease
Healthy control persons		Age matched healthy persons

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Conversion from Mild Cognitive Impairment to Alzheimers disease	The primary outcome measure is progression of clinical symptoms to an extent where the formal NINCDS-ADRDA criteria for dementia is meet. The progression is based upon clinical symptoms as well as explorative determinants in form of clinical tests, CSF analysis and qEEG analysis.	Every year in totally of 3 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

For patients:

age 50 to 90
diagnosed with MCI or AD
cerebrospinal fluid examination and EEG performed at baseline

For control persons:

age 50 to 90
MMSE score equal or above 26
ACE score equal or above 85
Normal physical examination, including normal blood samples, CT of cerebrum and EEG examination

Exclusion Criteria:

Pregnant or breastfeeding
psychiatric disease, former depression is allowed if antidepressive treatment has been initiated of a leat 3 months duration
Neurologic or somatic disease, including former severe head trauma or neuroinfection
Antipsychotic treatment
Former severe abuse of alcohol, medication or drugs
ECT treatment or anaesthesia within the last 3 months
no closely related person to assist the patient

Additionally exclusion criteria for healthy control persons:

meet the diagnostic criteria for MCI or AD

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with MCI and AD will be recruitted among consectutively refered patients in a memory clinic. Participation is voluntary Healthy control persons will be recuitted by posters and notices

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Malene s Nielsen, MD	Contact	0045 2868 0034		malni@regionsjaelland.dk
Peter Høgh, MD, Ph.D	Contact	0045 4732 2809		phh@regionsjaelland.dk

Overall Officials

Name	Affiliation	Role
Malene S Nielsen, MD	Roskilde Hospital, Department of Neurology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Neurologisk Afd, Roskilde Sygehus	Recruiting	Roskilde		4000	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D000544	Alzheimer Disease
D060825	Cognitive Dysfunction

Ancestor Terms

ID	Term
D003704	Dementia
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided