NCT00357357CompletedPhase 2
Clinical Safety/Tolerability of HF0220 and Its Effect on Biochemical Markers Relevant to Patients With a Diagnosis of Mild to Moderate Alzheimer' Disease
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Hunter-Fleming Ltd
- Enrollment
- 40
- Locations
- 10
- Primary Endpoint
- Safety/tolerability of HF 0220 in mild to moderate Alzheimer's patients
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 55 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Group1
Placebo Comparator
4x 7 day rising dose
Intervention: HF0220 (Drug)
Group2
Placebo Comparator
4x, 7 day rising dose
Intervention: HF0220 (Drug)
Group3
Placebo Comparator
28 day fixed lower dose
Intervention: HF0220 (Drug)
Group4
Placebo Comparator
28 day fixed upper dose
Intervention: HF0220 (Drug)
Outcomes
Primary Outcomes
Safety/tolerability of HF 0220 in mild to moderate Alzheimer's patients
Time Frame: June 2008
Secondary Outcomes
- Validate biochemical markers relevant to Alzheimer's disease(June 2008)
- Assess the suitability of chosen HF0220 dose levels for future studies(June 2008)
Investigators
Study Sites (10)
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