An Open-Label Extension of the Phase III Study CL-758010 with Alzhemed™ in Patients with Alzheimer’s Disease.

• Conditions: Alzheimer's Disease (AD) is an irreversible, progressive neurodegenerative disorder, characterized by gradual cognitive decline, abnormal behaviour, and personality changes.; MedDRA version: 9.1Level: LLTClassification code 10001896Term: Alzheimer's disease

• Registration Number: EUCTR2006-006490-24-FR
• Lead Sponsor: eurochem Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03-06
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 650

Inclusion Criteria

1) The patient must have completed the 78-week treatment period of the double-blind CL-758010 study.
2) Female patients must be of non-childbearing potential (i.e. surgically sterilized or at least two years post-menopausal).
3) Male subjects who are sexually active must:
a. Be proven to be sterile e.g. vasectomy or;
b. Use appropriate contraceptive barrier methods, e.g. a condom.
For the latter, in the event where the participant cannot reliably use/or is unable to use contraceptive barriers, his partner (if of childbearing potential) should be instructed to use appropriate contraceptive devices or methods to avoid pregnancy.
4) The patient must be living in a community with a reliable caregiver that will be attending each clinic visit, completing required evaluations, supervising and ensuring the administration of all doses of medication during the entire study. A reliable caregiver is an individual who has daily contacts with the patient (e.g. visits and/or phone calls). For consistency, it is recommended to have the same caregiver accompanying the patient at each visit. Patients living in assisted living facilities may be included in the study as long as the study medication intake is supervised and that the patient has a reliable caregiver. Due to the length of this study, it is highly recommended to identify other potential caregivers during the screening evaluation.
5) There must be signed informed consent from the patient or legal representative and the caregiver.
6) The potential participant must be able to perform the required psychometric tests and evaluations. Visual and auditory acuity (with glasses or hearing aid, if required) must be sufficient to complete the protocol-specified measures.

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

1) The patient has acquired immune deficiency syndrome (AIDS) or is positive for the human immunodeficiency virus (HIV), as revealed through medical history.
2) The patient has an allergy and/or hypersensitivity to any component of the study medication.
3) The patient has a history of drug or alcohol abuse within the previous five years.
4) The patient has a clinically significant and/or uncontrolled medical condition that, in the opinion of the treating physician, would pose a safety risk if the patient continued taking the study medication.
5) The presence of a significant nutritional deficiency, as defined by a Mini Nutritional Assessment (MNA) score of less than 17.
6) The patient has a clinical condition that might interfere with the interpretation of safety results.
7) The patient has a condition that can significantly affect the absorption of the study medication.
8) The patient participates in another trial during the study.
9) The patient is unable to swallow medication tablets.
10) The patient is otherwise unsuitable for this type of trial as determined by the treating physician.

Study & Design

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