Long-term Safety and Efficacy of Galantamine in Alzheimer's Disease

NCT00304629 | Completed Phase 3

• 1 other identifier: CR012070
• Study Type: interventional
• Target: 241
• Locations: 0 countries
• Sites: N/A

Brief Summary

The long-term safety and efficacy of galantamine (12 mg bid) will be documented during a one year open-label treatment in subjects with Alzheimer's Disease who completed the GAL-INT-8 trial (up to 400 eligible patients). Safety will be tracked by means of adverse event reports, laboratory parameters and physical exam. Long-term efficacy will be evaluated by means of a Alzheimer's Disease Assessment Scale(ADAS) and activities of daily living scale Disability Assessment for Dementia Scale(DAD)

Conditions

Alzheimer Disease

Keywords

Alzheimer's disease; cholinesterase inhibitors; galantamine

Outcome Measures

Primary Outcomes (1)

• The primary outcome is safety as measured by adverse events, laboratory tests, vital signs, weight, physical exam and electrocardiogram

Secondary Outcomes (1)

• The secondary outcome is effectiveness as measured by a cognitive scale (ADAS) and by activities of daily living (DAD).

Interventions

galantamine DRUG

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have taken trial medication during the 24-month trial period of GAL-INT-8 and should be enrolled within 1 month after completion
• Patients and their primary caregiver give informed consent for the participation in the trial
• Patients must have remained in good health, as determined by medical history, complete physical examination and laboratory tests

You may not qualify if:

• If a patient developed, during the trial GAL-INT-8, symptoms of other neurological or psychiatric diseases that might contribute to dementia, the subject cannot be enrolled. This includes subjects developing neurodegenerative disorders such as Parkinson's disease, Pick's disease or Huntington's chorea, or Creutzfeldt-Jacob disease, and subjects with cognitive impairment resulting from stroke, acute cerebral trauma, hypoxic cerebral damage, infection or primary or metastatic cerebral neoplasia
• Subjects with the following co-existing medical conditions: a) Any history of epilepsy or convulsions except for febrile convulsions during childhood b) Peptic ulcer: if the ulcer is considered to be still "active", i.e., if treatment for this condition started \<3 months ago or if treatment is not successful (symptoms still present), the subject is not eligible. c) Clinically significant hepatic, renal, pulmonary, metabolic or endocrine disturbances
• Patients with current, clinically significant cardiovascular disease that would be expected to limit the subject's ability to complete a 12-month trial. The following would usually be considered clinically significant cardiovascular disease: a) Unstable angina
• angina or coronary artery disease that required a change in medication (anti-angina or digitalis) within the last 3 months b) Decompensated congestive heart failure i.e. when symptoms occur in a subject on stable medication during rest or light exercise (NYHA III and IV). Note: if the only signs of decompensation are pretibial or malleolar oedema and the exercise tolerance is still reasonable (absence of dyspnoea) the subject should not be excluded c) Cardiac disease potentially resulting in syncope, near syncope or other alterations of mental status
• Patients using any agent for the treatment of dementia (approved, experimental, including over the counter agents), including, but not limited to nootropic agents, cholinomimetic agents, choline, oestrogens taken without medical need, chronic NSAIDs (30 consecutive days), vitamin E more than 30 IU daily, and deprenyl
• Conditions that could interfere with the absorption of the compound or with the evaluation of the disease

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead

Related Publications (2)

• Lim AWY, Schneider L, Loy C. Galantamine for dementia due to Alzheimer's disease and mild cognitive impairment. Cochrane Database Syst Rev. 2024 Nov 5;11(11):CD001747. doi: 10.1002/14651858.CD001747.pub4.

  PMID: 39498781 DERIVED

• Rockwood K, Dai D, Mitnitski A. Patterns of decline and evidence of subgroups in patients with Alzheimer's disease taking galantamine for up to 48 months. Int J Geriatr Psychiatry. 2008 Feb;23(2):207-14. doi: 10.1002/gps.1864.

  PMID: 17621382 DERIVED

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Galantamine

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amaryllidaceae Alkaloids; Alkaloids; Heterocyclic Compounds; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

  Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 17, 2006
• First Posted: March 20, 2006
• Study Start: March 1, 2000
• Study Completion: March 1, 2002
• Last Updated: February 1, 2011

Record last verified: 2011-01