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

This study has been completed.
Sponsor:
Information provided by:
Hunter-Fleming Ltd
ClinicalTrials.gov Identifier:
NCT00357357
First received: July 26, 2006
Last updated: August 20, 2008
Last verified: August 2008
  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 2

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

Resource links provided by NLM:


Further study details as provided by Hunter-Fleming Ltd:

Primary Outcome Measures:
  • Safety/tolerability of HF 0220 in mild to moderate Alzheimer's patients [ Time Frame: June 2008 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Validate biochemical markers relevant to Alzheimer's disease [ Time Frame: June 2008 ] [ Designated as safety issue: No ]
  • Assess the suitability of chosen HF0220 dose levels for future studies [ Time Frame: June 2008 ] [ Designated as safety issue: Yes ]

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
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00357357

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
Sponsors and Collaborators
Hunter-Fleming Ltd
Investigators
Principal Investigator: David Wilkinson Chief Principal Investigator
Principal Investigator: Niels Andreasen, Dr Swedish Co-Ordinating Principal Investigator
  More Information

Publications:
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

Keywords provided by Hunter-Fleming Ltd:
Alzheimer's disease

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 28, 2014