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

Phase 2
Completed
Conditions
Alzheimer's Disease
Interventions
Registration Number
NCT00357357
Lead Sponsor
Hunter-Fleming Ltd
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
40
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Group1HF02204x 7 day rising dose
Group3HF022028 day fixed lower dose
Group4HF022028 day fixed upper dose
Group2HF02204x, 7 day rising dose
Primary Outcome Measures
NameTimeMethod
Safety/tolerability of HF 0220 in mild to moderate Alzheimer's patientsJune 2008
Secondary Outcome Measures
NameTimeMethod
Validate biochemical markers relevant to Alzheimer's diseaseJune 2008
Assess the suitability of chosen HF0220 dose levels for future studiesJune 2008

Trial Locations

Locations (10)

King George Hospital

🇮🇳

Visakhapatnam, Andh Prad, India

Madras Medical College & Government General Hospital

🇮🇳

Chennai, Tamilnadu, India

Sree Chitra Tirunal Institute for Medical Sciences and Technology

🇮🇳

Thiruvananthapuram, Kerala, India

Research Institute for Care of the Elderly

🇬🇧

Bath, United Kingdom

Memory Assessment and Research Centre

🇬🇧

Southampton, United Kingdom

Kingshill Research Centre

🇬🇧

Swindon, United Kingdom

Karolinksa Institute

🇸🇪

Stockholm, Sweden

Manipal Hospital,

🇮🇳

Bangalore, Karna, India

Malmo University Hospital

🇸🇪

Malmo, Sweden

Nizam's Institute of Medical Sciences,

🇮🇳

Hyderabaad, Panjagutta, India

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