NCT00627848

Brief Summary

The purpose of the study is to investigate the effect of rivastigmine given as an acute dose compared to placebo and after 1 month chronic dosing on fMRI response during a face recognition task. Furthermore, the aim is to investigate whether fMRI response is correlated with long term treatment effect at 6 months and 12 months.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable alzheimer-disease

Timeline
Completed

Started Mar 2007

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

March 1, 2007

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

February 22, 2008

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 3, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

October 28, 2011

Status Verified

October 1, 2011

Enrollment Period

1.8 years

First QC Date

February 22, 2008

Last Update Submit

October 27, 2011

Conditions

Alzheimer' Disease

Keywords

Alzheimer's diseasefmriface recognitionrivastigmine

Outcome Measures

Primary Outcomes (1)

  • FMRI response in face recognition task

    at baseline and at 1 mo

Secondary Outcomes (1)

  • treatment response measured by ADAS-cog

    at 6 month and 1 year

Interventions

rivastigmineDRUG

Acute dose 3 mg or placebo. Thereafter 1.5 mg x 2 ad 30 days and thereafter increasing the dose upto 4.5 mg x 2 according to instructions.

Eligibility Criteria

Age55 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Probable Alzheimer's disease according to the NINCDS-ADRDA criteria
  • mild disease, CDR 1
  • the clinician is planning to start anticholinesterase treatment

You may not qualify if:

  • cognitive impairment for other reason than Alzheimer's disease
  • severe depression
  • other unstable physical disease
  • medal in body prevention MRI examination, claustrophobia
  • cardiac pacemaker
  • other significant neurologic or psychiatric disease
  • contraindication for anticholinesterase treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kuopio University Hospital

Kuopio, 70211, Finland

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Rivastigmine

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PhenylcarbamatesCarbamatesAcids, AcyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Hilkka Soininen

    Kuopio University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 22, 2008

First Posted

March 3, 2008

Study Start

March 1, 2007

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

October 28, 2011

Record last verified: 2011-10

Locations

FI(1)