A randomised, Double blind, placebo controlled trial of long term (2 years) Treatment of Galantamine in mild to moderately severe Alzheimer's Disease (AD) - GAL-ALZ-3005

• Conditions: Mild to Moderately-severe Alzheimer?s Disease; MedDRA version: 9.1Level: HLTClassification code 10001897Term: Alzheimer's disease (incl subtypes)

• Registration Number: EUCTR2007-002780-27-IT
• Lead Sponsor: Janssen-Cilag International

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11-19
• Last Update Posted: 9 October 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

Outpatients (men or women), 45 to 90 years of age, inclusive
Women must be postmenopausal (for at least 1 year), surgically sterile, sexually abstinent or if sexually active be practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) before entry and throughout the study. Women of childbearing potential must have a negative serum  hCG or urine pregnancy test at screening and at times as deemed appropriate by the investigator.
Diagnosed with mild to moderately-severe, probable or possible AD established in accordance with the criteria defined by the NINCDS ADRDA or DSM-IV. Subjects presenting with AD, with or without CVD may be enrolled. Refer to Attachment 1, NINCDS ADRDA Criteria for the Clinical Diagnosis of Alzheimer?s Disease (AD), and Attachment 2, DSM-IV Criteria for Diagnosis of Alzheimer?s Dementia.
A computed tomography (CT) or magnetic resonance imaging (MRI) of the head done since the onset of symptoms leading to the diagnosis of AD
An MMSE score of 10 to 26 inclusive, at screening (Visit 1)
Be living at home or in residential/nursing homes
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Neurodegenerative disorders other than AD, such as Parkinson?s Disease, Frontotemporal Dementia or Huntington?s disease
Any of the following conditions which may contribute to dementia:
?Clinically significant cerebral trauma
?Vascular dementia without AD. Note: Patients with dementia due to AD and significant CVD may be enrolled.
?Clinically significant hypoxic cerebral damage, either chronic or acute (e.g., occurring after cardiac arrest or severe hypotension)
?Vitamin deficiency states such as folate, vitamin B12 and other B complex deficiencies (e.g., thiamine deficiency in Korsakoff?s syndrome). For subjects with a history of vitamin B12 or folate deficiency, adequate vitamin replacement therapy must have been initiated and maintained for at least 1 month prior to screening

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified