Alzheimer' DiseaseADFRMINCT00627848
Rivastigmine in Mild Alzheimer's Disease, FMRI Study
A study testing rivastigmine in people with Alzheimer' Disease, run by Kuopio University Hospital at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Alzheimer' Disease
- What is being tested?
- rivastigmine
- How many people
- 20 participants
- Where
- 1 siteFinland
- Study dates
- Mar 2007to Dec 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Probable Alzheimer's disease according to the NINCDS-ADRDA criteria
- mild disease, CDR 1
- the clinician is planning to start anticholinesterase treatment
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Rivastigmine on FMRI in Mild Alzheimer's Disease
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.
- Conditions
- Alzheimer' Disease
- Being tested
- rivastigmine
- Keywords
- Alzheimer's disease, fmri, face recognition, rivastigmine
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
FMRI response in face recognition task
Measured: at baseline and at 1 mo
Secondary outcomes (1)
treatment response measured by ADAS-cog
Measured: at 6 month and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2008 (estimated)
- Study startMar 2007
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer' DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hilkka Soininen, Kuopio University Hospital
- Investigators
- Hilkka Soininen, Principal investigator, Kuopio University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00627848
- Sponsor's protocol ID
- KUH5772749
- Acronym
- ADFRMI
- Status last verified
- Oct 2011
- First submitted
- 22 Feb 2008
- Last updated
- 28 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Rivastigmine on FMRI in Mild Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT00627848
- Acronym / sponsor ID
- ADFRMI / KUH5772749
- Conditions
- Alzheimer' Disease
- Keywords
- Alzheimer's disease, fmri, face recognition, rivastigmine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 3 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Probable Alzheimer's disease according to the NINCDS-ADRDA criteria
- mild disease, CDR 1
- the clinician is planning to start anticholinesterase treatment
Key exclusion criteria (7 listed)
- cognitive impairment for other reason than Alzheimer's disease
- severe depression
- other unstable physical disease
- medal in body prevention MRI examination, claustrophobia
- cardiac pacemaker
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rivastigmineAcute 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. | Drug | – |
Primary outcome
FMRI response in face recognition task
Time frame: at baseline and at 1 mo
1 secondary outcome
treatment response measured by ADAS-cog
Time frame: at 6 month and 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hilkka Soininen principal investigator
Kuopio University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rivastigmine in people with Alzheimer' Disease, run by Kuopio University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FMRI response in face recognition task (time frame: at baseline and at 1 mo). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2011.