A Phase III Study of the Efficacy and Safety of Alzhemed™ as Add-on Therapy in Mild to Moderate Alzheimer's Disease Patients.

• Conditions: Alzheimer’s Disease (AD) is an irreversible, progressive neuro-degenartive disorder, characterized by gradual cognitive deficits associated with abnormal behaviour, personality changes, and which ultimately leads to dementia.Cerebral amyloid angiopathy (CAA) has also been found to be particularly common in Alzheimer patients.; MedDRA version: 8.1Level: LLTClassification code 10001896Term: Alzheimer's disease

• Registration Number: EUCTR2004-003435-31-DE
• Lead Sponsor: eurochem Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-08-24
• Last Update Posted: 1 May 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 930

Inclusion Criteria

1) Potential participants must be 50 years of age or older.
2) Female subjects must be of non-childbearing potential (i.e. surgically sterilized or at least 2 years post-menopausal).
3) Male subjects who are sexually actuve must: i) Be proven to be sterile e.g. vasectomy or; ii) Use appropriate contraceptive barrier methods, e.g. a condom
4) Diagnosis of dementia based on the Diagnostic and Statistical Manual, 4th edition
(DSM-IV) criteria
5) Diagnosis of probable AD based on the National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer’s Disease and Related Disorders Association (NINCDS-ADRDA criteria)
6) Severity of dementia of mild to moderate degree as reflected by a score of 16-26 (inclusive) on the MMSE performed at the screening visit.
7) The potential participant must be living in a community with a reliable caregiver that will attend each clinic visit, complete required evaluations, supervise and ensure that all doses of medication are administered appropriately during the entire study. A reliable caregiver is an individual who has daily contacts (including visits and/or phone calls) with the participant. For consistency, it is recommended to have the same caregiver accompanying the participant at each visit. Participants living in assisted living facilities may be included in the study as long as the study medication intake is supervised and the participant has a reliable caregiver. Due to the length of this study, it is highly recommended to identify other potential caregivers during the screening evaluation.
8) 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 procedures.
9) The potential participant must have a Geriatric Depression Scale (GDS) result of <10.
10) The potential participant must be treated with an AChEI (i.e., donepezil, galantamine or rivastigmine) and must be on a stable therapeutic dose regimen for at least 4 months prior to the screening visit and during the entire study.
11) The potential participant treated with one of the following medications must be on stable doses for at least 1 month prior to the screening visit and during the entire study: anxiolytics, sedatives, hypnotics, antidepressants, antipsychotics, anticonvulsants, estrogens and statins.
12) The potential participant on vitamin E should not have an intake of more than 2050 IU/day for at least 1 month prior to the screening visit and during the entire study.
13) If the potential participant has any other clinically significant medical condition (other than AD), it has to be stable for at least 3 months prior to the screening visit.
14) The following screening tests must be within normal limits or determined as not clinically significant by the study physician for participant’s sex and age:
a. Routine 12-lead electrocardiogram (ECG),
b. Cranial computerized tomography (CT) or Magnetic resonance imaging (MRI) scan performed within 2 years prior to the end of the screening period and after the onset of AD symptoms.
c. Clinical laboratory test battery
15) Fluency (oral and written) in the language in which the standardized tests will be administered.
16) Signed informed consent from potential participant or legal representative and caregiver.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 year

Exclusion Criteria

1) Potential participants with any other cause of dementia as evidenced by medical history, general physical and neurological examination, laboratory tests, and neuro-radiological findings.
2) Acquired immune deficiency syndrome (AIDS) positive through medical history or HIV positive.
3) Allergy and/or hypersensitivity to any component of the study medication.
4) Life expectancy less than 2 years.
5) History or current evidence of seizure disorder or convulsions.
6) History of drug or alcohol abuse within the previous 5 years or prior prolonged history.
7) Current evidence or history within the past 2 years of myocardial infarction, congestive heart failure (greater than class 1 of the NYHA guidelines), cerebrovascular accident and/or transient ischemic attack.
8) Potential participant with a clinically significant and/or uncontrolled cardiovascular, renal, hepatic, pulmonary (including severe asthma), gastrointestinal, endocrine, metabolic, ophthalmologic, immunologic or hematologic condition or other significant medical disease.
9) Presence of any clinical condition that might interfere with the interpretation of efficacy and safety results.
10) The presence of a significant nutritional deficiency, as assessed by the Mini Nutritional Assessment (MNA), as defined by a MNA score of less than 17.
11) Any condition that can significantly affect the absorption of the study medication.
12) ALT, ALP or AST > 2 times the upper limit of normal ranges and total bilirubin > 2 times the upper limit of normal.
13) Clinically significant deficiency in serum B12 or folate.
14) Use of memantine in the 4 months prior to the screening visit and during the course of the study.
15) Previous use of an investigational anti-amyloid or vaccine treatment for AD.
16) Participation in another drug trial within 30 days prior to the screening visit or during the study.
17) Potential participant has had previous exposure to AlzhemedTM.
18) Any medical condition/device that might interfere with the performance of the MRI (MRI subset only).
19) Any medical condition and/or medication that might interfere with the lumbar puncture procedure (LP subset only).
20) Inability of participant or legal representative and caregiver to provide a signed informed consent form.
21) Inability to swallow medication tablets.

Study & Design

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