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

• Status: Unknown status
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Ludwig-Maximilians - University of Munich
• Treatments: Galantamine

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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