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Clinical Trials/NL-OMON38134
NL-OMON38134
Completed
Not Applicable

Study to investigate the association between the response to a cholinergic challenge with galantamine and the clinical response to subsequent treatment with galantamine in patients with mild to moderate Alzheimer's Disease - A cholinergic challenge preceding galantamine treatment in patients with AD

Centre for Human Drug Research0 sites50 target enrollmentTBD
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Conditionsneurodegeneratieve aandoeningenAlzheimer's Diseasedementia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
neurodegeneratieve aandoeningen
Sponsor
Centre for Human Drug Research
Enrollment
50
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • •\- Outpatients
  • •\- Diagnosis of probable AD (according to NINCDS\-ADRDA)26
  • •\- Severity of dementia must be mild to moderate according to Clinical Dementia Rating Score (CDR of 0\.5 \- 2\)
  • •\- No contraindication for treatment with a CEI
  • •\- Mini Mental State Exam score of 18\-26 inclusive
  • •\- Assessed by the treating neurologist as mentally capable of understanding the implications of study participation
  • •\- Presence of an informant/caregiver at the information visit, signing of informed consent, and all study visits
  • •\- Signed informed consent by patient and caregiver

Exclusion Criteria

  • •\- Bedridden
  • •\- Severe asthma
  • •\- Metabolic disorders interfering with absorbtion, distribution or excretion of galantamine
  • •\- Pre\-existing psychiatric disease
  • •\- Other causes that can explain cognitive symptoms
  • •\- Use of neuroleptics
  • •\- Use of anticholinergics (e.g. oxybutinin, mebeverine, ipratropium(bromide))
  • •\- Use of benzodiazepine within 48 hours before a study day
  • •\- Prior or current use of a CEI (rivastigmine, galantamine, donepezil)
  • •\- Alcohol abuse (defined as use of alcohol despite significant areas of dysfunction, evidence of physical dependence, and/or related hardship due to alcohol)

Outcomes

Primary Outcomes

Not specified

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