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| Sponsor: | Hunter-Fleming Ltd |
|---|---|
| Information provided by: | Hunter-Fleming Ltd |
| ClinicalTrials.gov Identifier: | NCT00357357 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Alzheimer's Disease |
Drug: HF0220 |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | Clinical Safety/Tolerability of HF0220 and Its Effect on Biochemical Markers Relevant to Patients With a Diagnosis of Mild to Moderate Alzheimer' Disease |
| Estimated Enrollment: | 40 |
| Study Start Date: | July 2006 |
| Study Completion Date: | August 2008 |
| Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Group1
4x 7 day rising dose
|
Drug: HF0220
comparison of different dosages of drug
|
|
Placebo Comparator: Group2
4x, 7 day rising dose
|
Drug: HF0220
comparison of different dosages of drug
|
|
Placebo Comparator: Group3
28 day fixed lower dose
|
Drug: HF0220
comparison of different dosages of drug
|
|
Placebo Comparator: Group4
28 day fixed upper dose
|
Drug: HF0220
comparison of different dosages of drug
|
Eligibility| Ages Eligible for Study: | 55 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
RECRUITMENT OF PARTICIPANTS IS PERFORMED ONLY BY STUDY SITES
INCLUSION CRITERIA:
Participants must meet the following inclusion criteria to be eligible.
EXCLUSION CRITERIA
Patients will not be eligible to participate in the study if they meet any of the following criteria:
Contacts and Locations| India | |
| King George Hospital | |
| Visakhapatnam, Andh Prad, India | |
| Manipal Hospital, | |
| Bangalore, Karna, India | |
| Sree Chitra Tirunal Institute for Medical Sciences and Technology | |
| Thiruvananthapuram, Kerala, India | |
| Nizam's Institute of Medical Sciences, | |
| Hyderabaad, Panjagutta, India | |
| Madras Medical College & Government General Hospital | |
| Chennai, Tamilnadu, India | |
| Sweden | |
| Malmo University Hospital | |
| Malmo, Sweden, S205D2 | |
| Karolinksa Institute | |
| Stockholm, Sweden, SE14186 | |
| United Kingdom | |
| Research Institute for Care of the Elderly | |
| Bath, United Kingdom, BA2 5RP | |
| Memory Assessment and Research Centre | |
| Southampton, United Kingdom, SO30 3JB | |
| Kingshill Research Centre | |
| Swindon, United Kingdom, SN1 4HZ | |
| Principal Investigator: | David Wilkinson | Chief Principal Investigator |
| Principal Investigator: | Niels Andreasen, Dr | Swedish Co-Ordinating Principal Investigator |
More Information
| Responsible Party: | Dr John Fox ,Chief Operations Officer, Hunter-Fleming Ltd |
| ClinicalTrials.gov Identifier: | NCT00357357 History of Changes |
| Other Study ID Numbers: | HF0220/003, 2005-005791-32 |
| Study First Received: | July 26, 2006 |
| Last Updated: | August 20, 2008 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency; Sweden: Medical Products Agency |
|
Alzheimer's disease |
|
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders |