NCT01112501

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2006

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 28, 2010

Completed
Last Updated

April 28, 2010

Status Verified

April 1, 2010

Enrollment Period

3.3 years

First QC Date

April 27, 2010

Last Update Submit

April 27, 2010

Conditions

Dementia

Keywords

DiagnosisDementiaImaging

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Subjects with possible/suspected early dementia

You may qualify if:

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

You may not qualify if:

  • unable to be scanned with SPECT/CT

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kuopio University Hospital

Kuopio, 70211, Finland

Location

MeSH Terms

Conditions

DementiaDisease

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 27, 2010

First Posted

April 28, 2010

Study Start

September 1, 2006

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

April 28, 2010

Record last verified: 2010-04

Locations

FI(1)