Alzheimer's DiseaseCASL-AD-01NCT00637442
Continuous Arterial Spin Labeling (CASL) MRI for Monitoring and Prediction of Drug Therapy in Alzheimers Disease (AD)
A study testing Reminyl retard in people with Alzheimer's Disease, run by University Hospital, Bonn at 1 site in Germany.
Trial summary
Examination of the correlation between the cerebral bloodflow and the clinical change under treatment with Reminyl retard® and the prediction of clinical change by measuring the cerebral bloodflow in patients with mild to moderate Alzheimer's Disease Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Reminyl retard
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2008to Dec 2010
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Possible Alzheimer's Disease according to ICD-10 and NINCDS-ADRDA
- Underwritten study consent
- No treatment with acetylcholinesterase inhibitors
- Mini-Mental-State Examination: 12-25 points
- Age: 50-80 Years
- Orale contraception for women of child-bearing age
Who cannot join
- Mental Disorders
- Other Diseases of the CNS
- Severe Illness
- Contraindication for MRI-Scan
- Contraindication for Galantamin (Reminyl retard®)
- Participation at other clinical trials
Trial locations and contacts
1 site in 1 country.
About this study
Examination of the correlation between the cerebral bloodflow and the clinical change under treatment with Reminyl retard® and the prediction of clinical change by measuring the cerebral bloodflow in patients with mild to moderate Alzheimer's Disease
- Conditions
- Alzheimer's Disease
- Being tested
- Reminyl retard
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reminyl retardDrug
retard tablets once a day WEEK1-4: 8mg; WEEK 5-8: 16mg, WEEK 9-24: 24mg
| Study group | Role | What they receive |
|---|---|---|
| CASL-MRI | Experimental | Drug monitoring with CASL-MRI for new diagnosed patients with mild to moderate Alzheimer's Disease treated with Reminyl Receives: Drug: Reminyl retard |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral perfusion
Measured: baseline and after 12 weeks
Secondary outcomes (4)
Change of Alzheimer Disease Assessment Scale, cognitive part (ADAScog)
Measured: baseline, after 12 and 24 weeks
Alzheimer's Disease Functional Assessment and Change Scale (ADFACS)
Measured: baseline, after 12 and 24 weeks
Neuropsychiatric Inventory (NPI)
Measured: baseline, after 12 and 24 weeks
Mini-Mental-Status-Examination (MMSE)
Measured: baseline, after 12 and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2008 (estimated)
- Study startFeb 2008
- Primary completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bonn
- Sponsor type
- University, hospital or other
- Collaborators
- Federal Ministry of Health, Germany
- Investigators
- Frank Jessen, MD, Principal investigator, University of Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00637442
- Sponsor's protocol ID
- University Bonn
- Acronym
- CASL-AD-01
- Status last verified
- Jul 2010
- First submitted
- 15 Feb 2008
- Last updated
- 9 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Arterial Spin Labeling (CASL) MRI for Monitoring and Prediction of Drug Therapy in Alzheimers Disease (AD)
- ClinicalTrials.gov ID
- NCT00637442
- Acronym / sponsor ID
- CASL-AD-01 / University Bonn
- Conditions
- Alzheimer's Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, BonnUniversity, hospital or other
- Collaborators
- Federal Ministry of Health, Germany
- Study start
- Feb 2008
- Primary completion
- Dec 2010 (estimated)
- First posted
- 18 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.
Examination of the correlation between the cerebral bloodflow and the clinical change under treatment with Reminyl retard® and the prediction of clinical change by measuring the cerebral bloodflow in patients with mild to moderate Alzheimer's Disease
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CASL-MRI | Experimental | Drug: Reminyl retardDrug monitoring with CASL-MRI for new diagnosed patients with mild to moderate Alzheimer's Disease treated with Reminyl |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Possible Alzheimer's Disease according to ICD-10 and NINCDS-ADRDA
- Underwritten study consent
- No treatment with acetylcholinesterase inhibitors
- Mini-Mental-State Examination: 12-25 points
- Age: 50-80 Years
Key exclusion criteria (6 listed)
- Mental Disorders
- Other Diseases of the CNS
- Severe Illness
- Contraindication for MRI-Scan
- Contraindication for Galantamin (Reminyl retard®)
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 |
|---|---|---|
| Reminyl retardretard tablets once a day WEEK1-4: 8mg; WEEK 5-8: 16mg, WEEK 9-24: 24mg | Drug | CASL-MRI |
Primary outcome
Cerebral perfusion
Time frame: baseline and after 12 weeks
4 secondary outcomes
Change of Alzheimer Disease Assessment Scale, cognitive part (ADAScog)
Time frame: baseline, after 12 and 24 weeks
Alzheimer's Disease Functional Assessment and Change Scale (ADFACS)
Time frame: baseline, after 12 and 24 weeks
Neuropsychiatric Inventory (NPI)
Time frame: baseline, after 12 and 24 weeks
Mini-Mental-Status-Examination (MMSE)
Time frame: baseline, after 12 and 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2010.
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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.
Frank Jessen, MD principal investigator
University of Bonn
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reminyl retard in people with Alzheimer's Disease, run by University Hospital, Bonn at 1 site in Germany.
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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 9 Nov 2010. 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 Germany. 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?
Results are not available in the source record.
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?
Cerebral perfusion (time frame: baseline and after 12 weeks). 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 9 Nov 2010.