Completed

Safety and Tolerability Study of Extended Release (ER) Galantamine in Alzheimer's Disease

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What is being tested

galantamine ER

Drug
Who is being recruted

Alzheimer's Disease

Over 60 Years
+30 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: May 2004

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Summary

Principal SponsorJohnson & Johnson Pharmaceutical Research & Development, L.L.C.
Last updated: May 20, 2011
Sourced from a government-validated database.Claim as a partner
Study start date: May 1, 2004Actual date on which the first participant was enrolled.

The purpose of this study is to evaluate the safety and tolerability of an extended release formulation of the drug galantamine using a rapid dose escalation regimen. To improve dosing convenience of the current formulation of galantamine, a new once daily dosing Extended Release (ER) formulation was developed. In a different large study, in which approximately 900 patients with Alzheimer's disease participated, efficacy of the Extended Release formulation was confirmed. During the first 8 weeks of treatment, nausea and vomiting occurred less frequently with the Extended Release than Intermittent Release formulation. This suggests that patients might better tolerate a rapid dose escalation to the initial maintenance dose of 16mg daily, thereby improving the risk/benefit ratio during the first 4 weeks of therapy, i.e. receiving more drug sooner. The trial objectives are: 1) to demonstrate the safety and tolerability of galantamine Extended Release 16 mg daily when titrated from 8 mg daily after one week; 2) to evaluate the effect of galantamine Extended Release on cognition as measured by the Mini Mental State Examination. Results from prior trials show that galantamine Intermittent Release (twice a day dosing) has a high rate of adverse events when dose escalations occur at one-week intervals. Therefore, current galantamine labelling recommends that the drug dose be escalated once every 4 weeks. The study hypotheis is that the rapid dose escalation of the Extended Release formulation in subjects with Alzheimer's disease is safe and well tolerated. Comparison of adverse event rates will be made to the first 8 weeks Reminyl Extended Release group of another trial in which the Extended Release formulation was titrated from 8 mg daily to 16 mg daily at 4 weeks. Subjects will receive galantamine Extended Release capsules by mouth starting at 8 mg daily and after one week will be titrated up to 16 mg daily. This dose will be maintained for 11 additional weeks. 8 mg of Galantamine Extended Release Capsules once daily for one week. After one week will be titrated up to 16 mg daily for 11 weeks.

Official TitleGalantamine ER Open Label Rapid Dose Escalation Trial in Alzheimer's Disease 
Principal SponsorJohnson & Johnson Pharmaceutical Research & Development, L.L.C.
Last updated: May 20, 2011
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
83 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are assigned to groups based on specific criteria, such as their medical history or a doctor's recommendation. This approach ensures that treatments are given to those who may benefit the most, based on known factors.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 60 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Alzheimer's Disease
Criteria
4 inclusion criteria required to participate
Male or female outpatients diagnosed with Alzheimer's Disease
Age >= 60 years
Presence of mild to moderate dementia as evidenced by Mini Mental State Examination (MMSE) score of 10-24 inclusive at screening
History of cognitive decline that had been gradual in onset and progressive over a period of at least six months
26 exclusion criteria prevent from participating
Neurodegenerative disorders
One of the following conditions possibly resulting in cognitive impairment: Acute cerebral trauma or injuries secondary to chronic trauma (such as boxing), hypoxic cerebral damage, whether or not due to acute or chronic cerebral hypoperfusion
Vitamin deficiency states, such as folate, vitamin B12 or other B complex deficiencies
Neurosyphilis or other infections resulting in cerebral abscesses, meningitis, or encephalitides such as AIDS

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives
Study Objectives
Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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CompletedNo study centers