Diffusion Tensor Weighted MRI in Alzheimer's Disease Modifying Treatment Effects of Galantamine (Reminyl®)

NCT00523666 | Unknown Phase 4 DMC

• 2 other identifiers: DTI001EudraCT 2005-003762-41
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Alzheimer's Disease

Keywords

Alzheimer's disease; diffusion tensor imaging

Study Arms (2)

1

ACTIVE COMPARATOR

Drug: Galantamine (Reminyl®)

2

PLACEBO COMPARATOR

Drug: Placebo/Galantamine (Reminyl®)

Interventions

Galantamine (Reminyl®) DRUG

8mg - 24mg

1

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

2

Eligibility Criteria

• Age: 55 Years - 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ludwig-Maximilians - University of Munich: lead

Study Sites (1)

Ludwig-Maximilian University of Munich

Munich, D-80336, Germany

RECRUITING

Related Publications (4)

• 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.

  PMID: 17166745 BACKGROUND

• Sydykova 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.

  PMID: 17164468 BACKGROUND

• Lim 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.

  PMID: 39498781 DERIVED

• Blautzik 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.

  PMID: 26796681 DERIVED

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Galantamine

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amaryllidaceae Alkaloids; Alkaloids; Heterocyclic Compounds; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Harald Hampel, MD

  Dementia Research Section and Memory Clinic, Department of Psychiatry, Nussbaumstrasse 7, 80336 Munich, Germany

  STUDY DIRECTOR

• Stefan Teipel, MD

  Dementia Research Section and Memory Clinic, Department of Psychiatry, Nussbaumstrasse 7, 80336 Munich, Germany

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefan Teipel, MD

CONTACT

+498951605860; stefan.teipel@med.uni-muenchen.de

Harald Hampel, MD

CONTACT

harald.hampel@med.uni-muenchen.de

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 29, 2007
• First Posted: August 31, 2007
• Study Start: September 1, 2006
• Study Completion: September 1, 2008
• Last Updated: August 31, 2007

Record last verified: 2007-08

Locations

DE (1)