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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON38134

Enrollment

Registered

2010-07-22

Start date

2011-06-20

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

neurodegeneratieve aandoeningen Alzheimer's Disease dementia

Interventions

Challenge: A single dose of galantamine 16 mg p.o. or placebo Treatment: galantamine 8 * 24 mg/day p.o., escalation according to standard practice

Eligibility

Age

18 Years to 99 Years

Inclusion 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

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.

Design outcomes

Primary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)