European Study of HF0220 in Mild to Moderate Alzheimer's Disease Patients

Study Overview
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Brief Summary
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The purpose of this Phase II study is to evaluate the safety and tolerability of HF 0220 in patients with Alzheimer's disease compared to placebo (inactive substance). The study will also validate biochemical markers as appropriate clinical end-points and to assess the suitability of chosen dose levels for future clinical studies.

Official Title
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Clinical Safety/Tolerability of HF0220 and Its Effect on Biochemical Markers Relevant to Patients With a Diagnosis of Mild to Moderate Alzheimer' Disease

Conditions
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Alzheimer's Disease

Intervention / Treatment
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* Drug: HF0220


Participation Criteria
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Eligibility Criteria
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RECRUITMENT OF PARTICIPANTS IS PERFORMED ONLY BY STUDY SITES INCLUSION CRITERIA: Participants must meet the following inclusion criteria to be eligible. Male or Female (age over 55 years). Females must be non-child-bearing potential. Male patients with female partners of child-bearing potential should use effective contraception for the duration of the Study. A diagnosis of probable Alzheimer's disease established in accordance with the National Institute of Neurological and Communicative Disorders and Stroke /Alzheimer's disease and Related Disorders Association (NINCDS-ADRDA) classification. Severity of dementia of mild to moderate as assessed by the Mini-Mental State Examination (MMSE) score of 12-24. Patients must be living in the community living with or have at least daily visits from a responsible carer. The carer should be capable of assisting with the patient's medication, and prepared to attend with the patient for assessment. Written consent should be obtained from the patient and responsible carer. EXCLUSION CRITERIA Patients will not be eligible to participate in the study if they meet any of the following criteria: Primary, secondary or pseudodementias other than probable Alzheimer's disease. Clinically significant and/or uncontrolled condition or other significant medical disease. If taking medication for symptoms of dementia, the patient must be stable on therapy and have been taking these for a minimum of 3 months prior to enrolment. Treatment within the previous 3 months with any drug known to have a well defined potential for hepatotoxicity. Non-steroidal or steroidal anti-inflammatory agents. However, patients stable on low dose aspirin (upto 300mg/day) for at least 3 month prior to enrolment will be eligible. Taking anti-oxidant supplements. Active smokers of tobacco. Considered to be malnourished (body mass index <19). Patients in whom a lumbar puncture is contra-indicated.

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Group1<br>4x 7 day rising dose | Drug: HF0220<br>* comparison of different dosages of drug<br>|
| Placebo Comparator: Group2<br>4x, 7 day rising dose | Drug: HF0220<br>* comparison of different dosages of drug<br>|
| Placebo Comparator: Group3<br>28 day fixed lower dose | Drug: HF0220<br>* comparison of different dosages of drug<br>|
| Placebo Comparator: Group4<br>28 day fixed upper dose | Drug: HF0220<br>* comparison of different dosages of drug<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety/tolerability of HF 0220 in mild to moderate Alzheimer's patients |  | June 2008 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validate biochemical markers relevant to Alzheimer's disease |  | June 2008 | 
| Assess the suitability of chosen HF0220 dose levels for future studies |  | June 2008 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alzheimer's disease