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

Hunter-Fleming

Status and phase: Completed; Phase 2

Conditions: Alzheimer's Disease

Treatments: Drug: HF0220

Study type: Interventional

Funder types: Industry

Identifiers

NCT00357357

HF0220/003

2005-005791-32

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 4 patient groups, including a placebo group

Group1

Placebo Comparator group

Description:

4x 7 day rising dose

Treatment:

Drug: HF0220

Group2

Placebo Comparator group

Description:

4x, 7 day rising dose

Treatment:

Drug: HF0220

Group3

Placebo Comparator group

Description:

28 day fixed lower dose

Treatment:

Drug: HF0220

Group4

Placebo Comparator group

Description:

28 day fixed upper dose

Treatment:

Drug: HF0220