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

Completed

Conditions: neurodegeneratieve aandoeningen
Alzheimer's Disease
dementia

Registration Number: NL-OMON38134

Lead Sponsor: Centre for Human Drug Research

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 50

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)
- Use of recreational drugs
- Concomitant use of inhibitors of CYP2D6 (a/o kinidine, paroxetine, fluoxetine) or of CYP3A4 (a/o ketoconazol, ritonavir)
- Any other condition that in the opinion of the investigator would complicate or compromise the study, or the well being of the subject.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Pharmacodynamics: adaptive tracking, facial encoding and recognition task,<br /><br>neuro-endocrine parameters (IGF, IGF-BP3), pharmaco-EEG, simple reaction time,<br /><br>VAS Bond & Lader (mood, alertness and calmness), a VAS for nausea, pupil size,<br /><br>eye movements, verbal n-back test, and the Visual Verbal Learning Test (15<br /><br>words)<br /><br>Pharmacokinetics: Plasma PK samples of galantamine<br /><br>Treatment follow-up: MMSE, NPI, ADAS-cog/13, DAD, CDR-sum of boxes</p><br>

Secondary Outcome Measures