Reminyl's Dual Mode of Action Provides Novel Approach for Treatment
7 April 2000, Stockholm -- Results from a new five-month study conducted by Janssen Research Foundation show that patients who were treated with Reminyl® (galantamine), a new treatment for Alzheimer's disease showed a significant improvement in their cognitive, functional and behavioural symptoms, when measured by commonly-used assessments of the severity of Alzheimer's disease. The study is being presented today for the first time at the International Stockholm/Springfield Symposium, a meeting of leading experts to discuss advances in Alzheimer's therapy.
After 5 months, patients who were treated with 16 mg/day and 24 mg/day of Reminyl had significantly better scores on all efficacy measures compared to placebo (p<0.001 for both doses). "For the first time, we are able to show that Reminyl has benefits not only on cognition, but on patients' ability to function, while also postponing the emergence of behavioural symptoms," commented Pierre Tariot, MD, a Reminyl investigator and professor of psychiatry, medicine and neurology at the University of Rochester Medical Center, New York. "Even the most basic improvement of symptoms, such as being able to prepare a meal on their own or remembering the events of the day, can provide relief for patients and often their caregivers."
Efficacy was measured using a variety of subscales including the Alzheimer's Disease Assessment Scale (ADAS-cog), which measures a patient's memory, language, orientation and other aspects of cognition; the Clinician's Interview-Based Impression of Change plus Caregiver Input (CIBIC-plus), which provides a global assessment of behaviour, general psychiatric symptoms, cognition and activities of daily living; the 23-item version of the Alzheimer's Disease Cooperative Study Inventory (ADCS-ADL), which also measures activities of daily living; and the NeuroPsychiatric Inventory (Inventory), which measures behavioural symptoms in Alzheimer's disease.
Long-Term Efficacy
An additional study presented at this meeting demonstrated Reminyl's long-term effectiveness for at least 12 months in helping people with Alzheimer's disease maintain their memory, learning and decision-making abilities. The multi-center, open-label six month extension study of 353 patients with mild-to-moderate Alzheimer's disease found that patients treated with 24 mg/day of Reminyl continuously for 12 months experienced maintenance at or above baseline as measured on the ADAS-cog. Previously, 636 patients had taken part in a six-month double-blind study, which was subsequently extended. Importantly, patients in this group were also able to maintain activities of daily functioning for one year.
"The results from this study show that ongoing, continuous treatment with Reminyl can help patients maintain daily functioning without further cognitive deterioration for an entire year," said Luc Truyen, MD, PhD, associate director, Global Clinical Research and Development, CNS, Janssen Research Foundation. "This is an important milestone in the treatment of Alzheimer's disease."
Novel Dual Mode of Action
Research indicates that Reminyl has a dual mechanism of action. A progressive lack of acetylcholine, caused by the death of acetylcholine neurones, is related to the symptoms of Alzheimer's disease. In addition to preserving levels of acetylcholine in the brain by blocking the action of the enzyme acetylcholinesterase (which inactivates acetylcholine), Reminyl also appears to act on the brain's nicotinic receptors. The "modulation" of these receptors could lead to release of more acetylcholine.1,2,3.
For further information please contact:
In London:
Ketchum
Roseann Ward: 44-171-465-8752
roseannward@yahoo.com
Louise Strong: 44-171-465-8752
louise_strong@hotmail.com
Notes to Editors:
Janssen Research Foundation, an affiliate of Janssen Pharmaceutica, is headquartered in Beerse, Belgium. Janssen-Cilag has operating companies in 32 countries, including the United States. A wholly owned subsidiary of Johnson & Johnson, it is a leader in central nervous system research. Other areas of research include anaesthesia, oncology and gastroenterology.
Shire Pharmaceuticals Group plc is an emerging pharmaceutical company focused primarily on two therapeutic areas: central nervous system disorders and metabolic bone disease, with sales, marketing and R&D operations in the UK and United States.
References:
1. Shrattenolz A et al. Agonist Responses of Neuronal Nicotinic Acetylcholine Receptors are Potentiated by a Novel Class of Allosterically Acting Ligands. Molecular Pharmacology. 1996; 49:1-6
Reminyl® (galantamine) is being developed by the Janssen Research Foundation, under a co-development agreement with UK-based Shire Pharmaceuticals Group plc. It was recently approved in Sweden, and is currently being considered for approval in Europe under the Mutual Recognition Procedure, and in other countries. A New Drug Application (NDA) was filed with the U.S. Food and Drug Administration (FDA) in September 1999. If approved, galantamine will be marketed under the trade name Reminyl® by Janssen Pharmaceutica in the United States, by Janssen-Ortho in Canada and by Janssen-Cilag elsewhere, with the exception of the UK and Ireland, where it will be sold by Shire under a co-promotion agreement with Janssen-Cilag.
2. Maelicke A. Nicotinic Receptors in the Central Nervous System. 6th International Conference on Alzheimer's Disease and Related Disorders. July 18, 1998; Amsterdam, The Netherlands
3. Vidal, C. Nicotinic Receptors in the Brain: Molecular Biology, Function, and Therapeutics. Molecular and Chemical Neuropathology. 1996;28:3-11