SPECT/CT in the Diagnosis of Dementia | NCT01112501

Studies
SPECT/CT in the Diagnosis of Dementia

NCT01112501

Sponsor

Kuopio University Hospital

Status

Completed

Last Update Posted

Apr 28, 2010Estimated

Enrollment

82Actual

Phase

Not provided

Conditions

Dementia

Interventions

Not provided

Countries

Finland

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

Apr 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2006

Primary Completion Date

Jan 2010Actual

Completion Date

Jan 2010Actual

First Submitted Date

Apr 27, 2010

First Submission Date that Met QC Criteria

Apr 27, 2010

First Posted Date

Apr 28, 2010Estimated

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

Apr 27, 2010

Last Update Posted Date

Apr 28, 2010Estimated

Name	Class
University of Eastern Finland	OTHER

Description Module

Brief Summary

Aim of the study is to evaluate whether Tc-99m-ECD-SPECT/CT enhances early diagnosis of dementia in two specific patient groups: (1) patient with mild cognitive impairment, and (2) patient with possible symptoms and signs of frontotemporal dementia. Evaluation of SPECT/CT data is performed both by visual and quantitative voxel-based analyses (Statistical Parametric Mapping). The final diagnosis is based on up to four years clinical follow-up.

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

No data available

No data is available for this block.

Enrollment

82Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Final diagnosis	(1) controls, (2) stable mild cognitive impairment (MCI), (3)MCI converted to Alzheimers's disease (AD), (4) frontotemporal dementia (FTD), suspected FTD converted to AD, (5) other final diagnoses	4 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria (one of these):

healthy control
mild cognitive impairment (recruited from a population based data)
clinically suspected frontotemporal dementia (unset diagnosis)

Exclusion Criteria:

unable to be scanned with SPECT/CT

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Subjects with possible/suspected early dementia

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kuopio University Hospital		Kuopio		70211	Finland

Condition Browse Module

MeSH Terms

ID	Term
D003704	Dementia
D004194	Disease

Ancestor Terms

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D019965	Neurocognitive Disorders

Browse Leaves

Not provided

Browse Branches

Not provided