Alzheimer's DiseasePhase 4NCT00523666
Diffusion Tensor Weighted MRI in Alzheimer's Disease Modifying Treatment Effects of Galantamine (Reminyl®)
A Phase 4 study testing Galantamine (Reminyl®) in people with Alzheimer's Disease, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
Trial summary
Alzheimer's disease (AD) is characterized by progressive subcortical and cortical neuronal degeneration. AD patients differ in the time course of neuronal degeneration and accompanying cognitive decline. Read more about this study
- Who is it for?
- Ages 55 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Galantamine (Reminyl®)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2006to Sep 2008
- Phase
- Phase 4
- 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 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- male of female patients aged ≥ 55years, fulfilling criteria of the National Institute of Neurological and Communicative Disease and Stroke (NINCDS) and the Alzheimer's Disease and Related Disorders Association (ADRDA) for the diagnosis of clinically probable AD
- MMSE score > 16
- no evidence for other psychiatric axis I disorders according to DSM- IV criteria
- no evidence for cerebrovascular disease (radiological confirmed), cardiac or cerebral infarct (three months before the study), thyroid disease and other neurodegenerative or neuroinflammatory disorders. No evidence for acute or unstable medical condition.
- no risk factors of hypertension, cardiac disease (e.g. angina pectoris, congestive heart failure, right bundle branch block, or arrhythmias), diabetes mellitus (stable within 3 months)
- no history of drug/alcohol abuse
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- no history of panic attacks or claustrophobia (due to requirements of the MRI examinination)
- no surgical implants or non-fixed metallic particles
- patient has not taken a previously approved cholinesterase inhibitor or memantine, which has been discontinued at least 6 weeks prior to the Screening
- patient is able to provide written Informed Consent to participate study. If, at investigator's discretion, a patient is considered not to be capable to give legal consent, then written consent must also be obtained from the patient's legally acceptable representative.
Who cannot join
- no evidence of memory or other cognitive impairments, verified by clinical history and cognitive testing
- previous or current history of degenerative or ischemic disorders of the peripheral or central nervous system
- previous or current history of systemic disorders
- no ability to participate and no willing to give informed consent and comply with the study restrictions
- MMSE score < 16 range
Trial locations and contacts
1 site in 1 country.
Harald Hampel, MD contact
Germany1 site, 1 recruiting
- Recruiting
Ludwig-Maximilian University of Munich
Munich, D-80336
Stefan Teipel, MD
Djyldyz Sydykova, MD
About this study
Official title: Diffusion Tensor Weighted MRI in Alzheimer's Disease: Prediction and Mapping of Symptomatic and Disease Modifying Treatment Effects of Galantamine (Reminyl®)
Alzheimer's disease (AD) is characterized by progressive subcortical and cortical neuronal degeneration. AD patients differ in the time course of neuronal degeneration and accompanying cognitive decline.
With recent advances in MR imaging, including optimized data acquisition and processing techniques, tools that are especially well suited for tracking long-term pathological changes as well as drug treatment effects have become available. In addition to structural imaging, new acquisition and analysis techniques have been developed to determine integrity of subcortical fiber tracts in vivo.
In the present project we propose to determine predictors of disease progression and treatment response and investigate potential treatment effects on structural disease progression, covering the continuum from axonal degeneration to cortical neuronal loss taking advantage of recent advances in MRI acquisition and analysis techniques.
Read the detailed description
The outlined project will provide data to determine the value of cortical and subcortical volumetric and diffusion markers of neuronal degeneration to predict disease progression and response to (acetyl-)cholinergic treatment with Galantamine (Reminyl®). Furthermore, analysis of longitudinal MRI data in respect to cortical and subcortical atrophy and fiber degeneration will provide an estimate of the potential of new MRI analysis techniques to determine effects of (acetyl-)cholinergic treatment on rates of disease progression. Finally, the proposed study will allow determining the potential value of a new MRI technique, diffusion tensor imaging, to show the morphological correlate of cortical disconnection in AD and to map progression and treatment related effects on subcortical fiber tract integrity in AD.
The major scientific value of this project is the combined description of the effect of Galantamine (Reminyl®) on disease progression on the structural level of analysis in AD. The data from this project may help to identify predictors of treatment response and to elucidate the mechanisms of drug action of Galantamine (Reminyl®) in AD.
- Conditions
- Alzheimer's Disease
- Being tested
- Galantamine (Reminyl®), Placebo/Galantamine (Reminyl®)
- Keywords
- Alzheimer's disease, diffusion tensor imaging
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Galantamine (Reminyl®)Drug
8mg - 24mg
Placebo/Galantamine (Reminyl®)Drug
Patients are treated double-blind with placebo for 6 months, followed by treatment with Galantamine (Reminyl®) for another 6 months.
Dose scheme: 8mg-24mg
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: Galantamine (Reminyl®) |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo/Galantamine (Reminyl®) |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2007 (estimated)
- Study startSep 2006
- Study completionSep 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Investigators
- Harald Hampel, MD, Study director, Dementia Research Section and Memory Clinic, Department of Psychiatry, Nussbaumstrasse 7, 80336 Munich, GermanyStefan Teipel, MD, Principal investigator, Dementia Research Section and Memory Clinic, Department of Psychiatry, Nussbaumstrasse 7, 80336 Munich, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00523666
- Sponsor's protocol ID
- DTI001
- Other IDs
- EudraCT 2005-003762-41
- Status last verified
- Aug 2007
- First submitted
- 29 Aug 2007
- Last updated
- 31 Aug 2007
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Teipel SJ, Stahl R, Dietrich O, Schoenberg SO, Perneczky R, Bokde AL, Reiser MF, Moller HJ, Hampel H. Multivariate network analysis of fiber tract integrity in Alzheimer's disease. Neuroimage. 2007 Feb 1;34(3):985-95. doi: 10.1016/j.neuroimage.2006.07.047. Epub 2006 Dec 12.
PubMed 17166745Sydykova D, Stahl R, Dietrich O, Ewers M, Reiser MF, Schoenberg SO, Moller HJ, Hampel H, Teipel SJ. Fiber connections between the cerebral cortex and the corpus callosum in Alzheimer's disease: a diffusion tensor imaging and voxel-based morphometry study. Cereb Cortex. 2007 Oct;17(10):2276-82. doi: 10.1093/cercor/bhl136. Epub 2006 Dec 12.
PubMed 17164468Lim AWY, Schneider L, Loy C. Galantamine for dementia due to Alzheimer's disease and mild cognitive impairment. Cochrane Database Syst Rev. 2024 Nov 5;11(11):CD001747. doi: 10.1002/14651858.CD001747.pub4.
PubMed 39498781Blautzik J, Keeser D, Paolini M, Kirsch V, Berman A, Coates U, Reiser M, Teipel SJ, Meindl T. Functional connectivity increase in the default-mode network of patients with Alzheimer's disease after long-term treatment with Galantamine. Eur Neuropsychopharmacol. 2016 Mar;26(3):602-13. doi: 10.1016/j.euroneuro.2015.12.006. Epub 2015 Dec 10.
PubMed 26796681
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diffusion Tensor Weighted MRI in Alzheimer's Disease: Prediction and Mapping of Symptomatic and Disease Modifying Treatment Effects of Galantamine (Reminyl®)
- ClinicalTrials.gov ID
- NCT00523666
- Acronym / sponsor ID
- DTI001
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimer's disease, diffusion tensor imaging
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Study start
- Sep 2006
- Study completion
- Sep 2008 (estimated)
- First posted
- 31 Aug 2007 (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.
Alzheimer's disease (AD) is characterized by progressive subcortical and cortical neuronal degeneration. AD patients differ in the time course of neuronal degeneration and accompanying cognitive decline.
With recent advances in MR imaging, including optimized data acquisition and processing techniques, tools that are especially well suited for tracking long-term pathological changes as well as drug treatment effects have become available. In addition to structural imaging, new acquisition and analysis techniques have been developed to determine integrity of subcortical fiber tracts in vivo.
In the present project we propose to determine predictors of disease progression and treatment response and investigate potential treatment effects on structural disease progression, covering the continuum from axonal degeneration to cortical neuronal loss taking advantage of recent advances in MRI acquisition and analysis techniques.
Detailed description
The outlined project will provide data to determine the value of cortical and subcortical volumetric and diffusion markers of neuronal degeneration to predict disease progression and response to (acetyl-)cholinergic treatment with Galantamine (Reminyl®). Furthermore, analysis of longitudinal MRI data in respect to cortical and subcortical atrophy and fiber degeneration will provide an estimate of the potential of new MRI analysis techniques to determine effects of (acetyl-)cholinergic treatment on rates of disease progression. Finally, the proposed study will allow determining the potential value of a new MRI technique, diffusion tensor imaging, to show the morphological correlate of cortical disconnection in AD and to map progression and treatment related effects on subcortical fiber tract integrity in AD.
The major scientific value of this project is the combined description of the effect of Galantamine (Reminyl®) on disease progression on the structural level of analysis in AD. The data from this project may help to identify predictors of treatment response and to elucidate the mechanisms of drug action of Galantamine (Reminyl®) in AD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Galantamine (Reminyl®) |
| 2 | Placebo comparator | Drug: Placebo/Galantamine (Reminyl®) |
Who may qualify
- Ages
- 55 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- male of female patients aged ≥ 55years, fulfilling criteria of the National Institute of Neurological and Communicative Disease and Stroke (NINCDS) and the Alzheimer's Disease and Related Disorders Association (ADRDA) for the diagnosis of clinically probable AD
- MMSE score > 16
- no evidence for other psychiatric axis I disorders according to DSM- IV criteria
- no evidence for cerebrovascular disease (radiological confirmed), cardiac or cerebral infarct (three months before the study), thyroid disease and other neurodegenerative or neuroinflammatory disorders. No evidence for acute or unstable medical condition.
- no risk factors of hypertension, cardiac disease (e.g. angina pectoris, congestive heart failure, right bundle branch block, or arrhythmias), diabetes mellitus (stable within 3 months)
Key exclusion criteria (5 listed)
- no evidence of memory or other cognitive impairments, verified by clinical history and cognitive testing
- previous or current history of degenerative or ischemic disorders of the peripheral or central nervous system
- previous or current history of systemic disorders
- no ability to participate and no willing to give informed consent and comply with the study restrictions
- MMSE score < 16 range
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 |
|---|---|---|
| Galantamine (Reminyl®)8mg - 24mg | Drug | 1 |
| Placebo/Galantamine (Reminyl®)Patients are treated double-blind with placebo for 6 months, followed by treatment with Galantamine (Reminyl®) for another 6 months. Dose scheme: 8mg-24mg | Drug | 2 |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2007.
- Background: PubMed 17166745Teipel SJ, Stahl R, Dietrich O, Schoenberg SO, Perneczky R, Bokde AL, Reiser MF, Moller HJ, Hampel H. Multivariate network analysis of fiber tract integrity in Alzheimer's disease. Neuroimage. 2007 Feb 1;34(3):985-95. doi: 10.1016/j.neuroimage.2006.07.047. Epub 2006 Dec 12.
- Background: PubMed 17164468Sydykova D, Stahl R, Dietrich O, Ewers M, Reiser MF, Schoenberg SO, Moller HJ, Hampel H, Teipel SJ. Fiber connections between the cerebral cortex and the corpus callosum in Alzheimer's disease: a diffusion tensor imaging and voxel-based morphometry study. Cereb Cortex. 2007 Oct;17(10):2276-82. doi: 10.1093/cercor/bhl136. Epub 2006 Dec 12.
- Derived from this study: PubMed 39498781Lim AWY, Schneider L, Loy C. Galantamine for dementia due to Alzheimer's disease and mild cognitive impairment. Cochrane Database Syst Rev. 2024 Nov 5;11(11):CD001747. doi: 10.1002/14651858.CD001747.pub4.
- Derived from this study: PubMed 26796681Blautzik J, Keeser D, Paolini M, Kirsch V, Berman A, Coates U, Reiser M, Teipel SJ, Meindl T. Functional connectivity increase in the default-mode network of patients with Alzheimer's disease after long-term treatment with Galantamine. Eur Neuropsychopharmacol. 2016 Mar;26(3):602-13. doi: 10.1016/j.euroneuro.2015.12.006. Epub 2015 Dec 10.
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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.
Harald Hampel, MD contact
Harald Hampel, MD study director
Dementia Research Section and Memory Clinic, Department of Psychiatry, Nussbaumstrasse 7, 80336 Munich, Germany
Stefan Teipel, MD principal investigator
Dementia Research Section and Memory Clinic, Department of Psychiatry, Nussbaumstrasse 7, 80336 Munich, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Galantamine (Reminyl®) in people with Alzheimer's Disease, run by Ludwig-Maximilians - University of Munich 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 10 inclusion and 5 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 31 Aug 2007. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Stefan Teipel, MD (+498951605860, stefan.teipel@med.uni-muenchen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00523666, which also lists 4 linked publications.
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 31 Aug 2007.