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Alzheimer's DiseasePhase 3NCT00082602

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

A Phase 3 study testing galantamine ER in people with Alzheimer's Disease, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Alzheimer's Disease
What is being tested?
galantamine ER
How many people
83 participants
Where
No sites listed yet
Study dates
May 2004to Apr 2005
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
  • Primary or metastatic cerebral neoplasia
  • Significant endocrine or metabolic disease e.g., untreated or uncontrolled thyroid, parathyroid or pituitary disease, Cushing's syndrome, severe renal failure or uncontrolled diabetes mellitus
Show all 26Show fewer
  • Mental retardation or oligophrenia
  • Multi-infarct dementia or clinically active cerebrovascular disease as evidenced by: a history of a significant cerebrovascular event yielding a physical or neurologic deficit likely to confound the assessment of the subject's intellectual function, multiple focal signs on neurological examination indicative of multiple ischemic attacks, significant findings on an available CT or MRI scan taken within the last 12 months
  • Subjects with the following co-existing medical conditions: Any history of epilepsy or convulsions except for febrile convulsions during childhood
  • Current clinically significant psychiatric disease, in particular current major depression, schizophrenia, bipolar disorder, moderate to severe or uncontrolled behavioral disturbances
  • Peptic ulcer disease: if the ulcer is considered to be still active, or if treatment is not successful (symptoms present)
  • Clinically significant hepatic, renal, pulmonary, metabolic or endocrine disturbances
  • Clinically significant urinary outflow obstruction
  • Current, clinically significant cardiovascular disease that would be expected to limit the subject's ability to participate in and complete a 12-Week trial. The following would usually be considered clinically significant cardiovascular diseases: cardiac surgery or myocardial infarction within the past 6 months, angina or coronary artery disease that required a change in anti-angina medication within the last 3 months, decompensated congestive heart failure, cardiac disease potentially resulting in syncope, near syncope or other alterations of mental status, atrial fibrillation, bradycardia < 50/min., atrio-ventricular block > first degree
  • Severe mitral or aortic valvular disease
  • Uncontrolled high blood pressure (systolic blood pressure > 170 mmHg or diastolic blood pressure > 110 mmHg) or sustained hypotension
  • Any agent being used for the treatment of dementia (approved, experimental or over the counter agents
  • Subjects who have previously received Cognexâ, Ariceptâ, metrifonate, Exelonâ, Reminyl, or Namendaâ for treatment of Alzheimer's disease, no matter if approved or experimental can be included in this trial provided that during the 30 days prior to baseline they were not taking these agents
  • O History of drug or alcohol abuse within the last year or prior prolonged history of the same
  • Female subjects of childbearing potential
  • Subjects who in the opinion of the investigator are otherwise unsuitable for a trial of this type
  • History of severe drug allergy or hypersensitivity, including recorded hypersensitivity to cholinesterase inhibitors, choline agonists or identical agents, or bromide
  • Subjects who have previously been enrolled in other galantamine trials
  • Subjects who have received an investigational medication within the last 30 days
  • Conditions that could interfere with the absorption of the compound or with the evaluation of the disease
  • Employees of the investigator

About this study

Official title: Galantamine ER Open Label Rapid Dose Escalation Trial in Alzheimer's Disease

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.

Read the detailed description

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.

Being tested
galantamine ER
Keywords
galantamine, Alzheimer's disease
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • galantamine ERDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The primary end point occurs at Week 8. The primary outcome measures will be tolerability and safety through rates of adverse events.

Secondary outcomes (1)

  1. The secondary end point occurs at Week 12. The secondary outcome measure will be the Mini Mental State Examination score.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 May 2004 (estimated)
  2. Study startMay 2004
  3. Study completionApr 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
83 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00082602
Sponsor's protocol ID
CR004699
Status last verified
Apr 2009
First submitted
12 May 2004
Last updated
20 May 2011
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing galantamine ER in people with Alzheimer's Disease, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 May 2011. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary end point occurs at Week 8. The primary outcome measures will be tolerability and safety through rates of adverse events.. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00082602.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2011.

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