Trial intelligence / Profile preview

Galantamine HBr long-term safety in MCI

NCT00240695Phase 3

Key facts

Status: Completed
Start: May 2003
Sponsor: Johnson & Johnson
Modality: Nucleic Acid-Directed Small Molecules, Classical Binding Small Molecules, Metabolically Activated Prodrugs

Drugs: galantamine
Conditions: Mild Cognitive Impairment (MCI)

Overview

Phase 3, open-label, single-arm trial of galantamine in Mild Cognitive Impairment (MCI), sponsored by Johnson & Johnson. Primary endpoints: Incidence of adverse events at 12 months, Changes in laboratory tests at 12 months and 2 more. Started May 2003; status: completed.

Design

1 arm

Study design: Non-randomizedOpen-label

Open-label Galantamine
Galantamine 8 or 12 mg twice daily

Who it enrols

Patients with Mild Cognitive Impairment who completed 24 months of double-blind treatment in previous galantamine studies (GAL-INT-11 or GAL-INT-18) without progressing to dementia (CDR < 1).

Endpoints

Primary

Incidence of adverse events12 months
Changes in laboratory tests12 months
Changes in ECGs12 months
Changes in physical examinations12 months

Secondary

Clinical Dementia Rating12 months
Alzheimer's Disease Assessment Scale: cognitive/MCI version12 months
Clinical Dementia Rating-Sum of the Boxes12 months
Short-Form 36 Health Survey12 months
Use of health and social care resources12 months
Time to conversion to dementia12 months

Beyond the preview

Go deeper on NCT00240695.

Full results, competitive context and analysis are in the Gosset platform.

Full results & analysis

Available in the Gosset platform where reported.

Competitive context

Available in the Gosset platform where reported.

Bring the full picture into focus.

See how Gosset can support your research on NCT00240695.