Canadian Study Shows Treatment For Alzheimer's Disease Can Significantly Reduce Verbal Repetition An Important Goal For Patients And Caregivers

Main Category: Alzheimer's / Dementia
Also Included In: Seniors / Aging;  Neurology / Neuroscience;  Clinical Trials / Drug Trials
Article Date: 16 Apr 2007 - 0:00 PDT


A new study published in Neurology showed that verbal repetition was significantly reduced in patients with Alzheimer's disease treated with REMINYL® (galantamine HBr), compared to placebo, when verbal repetition was set as a treatment goal. Fifty-eight per cent of patients on REMINYL® experienced a reduction in verbal repetition, a common and bothersome symptom of Alzheimer's disease, compared to 24 per cent of patients on placebo.2,3,4,1 This new data comes from an analysis of the VISTA trial (Video-imaging Synthesis of Treating Alzheimer's disease), the first placebo controlled study of its kind to look at individualized treatment outcomes in each patient with Alzheimer's disease enrolled in a clinical trial.

Repetitive behaviours are some of the most common behavioural and psychological symptoms of Alzheimer's disease and other dementias.2 Of these, repetitive verbalization such as asking the same question multiple times, or telling the same story repeatedly is particularly stressful for caregivers, and reducing verbal repetition is a common treatment goal.4,3

Improvement in problem behaviours like repetitive questioning, story telling or uncontrollable repetition of a word, action or phrase (also referred to as perseveration), may be especially important to caregivers, as these have been shown to be a major factor in caregiver's decisions to institutionalize their loved ones.1,5,6.

"Verbal repetition is a common hallmark of Alzheimer's disease and is a challenge for patients and caregivers alike," said Dr. Kenneth Rockwood, lead investigator and professor, Division of Geriatric Medicine, Dalhousie University and staff physician, Department of Medicine, Queen Elizabeth II Health Sciences Centre, Halifax. "The VISTA analysis confirms that this frustrating symptom can be reduced with therapy such as REMINYL®."

In a secondary analysis of 130 patients with Alzheimer's disease from the VISTA trial, reducing verbal repetition was listed as a treatment goal for 44 per cent of randomized patients.1 And, for over 80 per cent of these patients, repetitive questioning was identified as their most common verbal repetition problem. The trial concluded that at four months of treatment, patients taking REMINYL® were significantly more likely to have met their treatment goal of reducing verbal repetition than those on placebo. The study also shows that reduction in verbal repetition is an indicator of overall treatment response - when repetition improved, patients were also more likely to achieve other pre-set goals.1

In a recent survey of Canadian caregivers, verbal repetition was listed as one of the top two triggers causing them to bring their loved one to the doctor.7 Verbal repetition is an early sign of Alzheimer's disease, and because it is easy to recognize and stressful for caregivers, it may prompt the initial doctor's visit and start the important chain of events to an eventual diagnosis of Alzheimer's disease.8,7

"It's important for people with Alzheimer's disease to have their symptoms recognized as illness," said Dr. Rockwood. "Many symptoms of Alzheimer's disease overlap with the usual changes seen with ageing, but repetitive questioning appears to be both an important sign of dementia, and an important goal for treatment. People should seek medical advice as soon as symptoms like repetition interfere with daily life."

About VISTA

The VISTA trial, which was conducted at 14 sites across Canada, was designed to evaluate the clinical meaningfulness of treatment with REMINYL® versus placebo in 130 mild to moderate Alzheimer's patients. To evaluate clinical meaningfulness, the primary outcomes were separate patient/caregiver and physician assessments of goal attainment, as measured by Goal Attainment Scaling (GAS). Prior to treatment, a median of three and no more than six goals per patient were set in the areas of cognition, function, leisure and social activity. Preset goals included playing the piano again, recognizing family and friends, reducing verbal repetition, and re-learning how to use the television remote control.9

The trial was a 16-week randomized, double-blind, placebo-controlled design with a 16-week open-label follow-up. Patients were randomly assigned to either treatment with REMINYL® (16-24 mg) or placebo.9 To better understand treatment effects, the physician and patient/caregiver interviews were digitally video recorded.9

In the placebo-controlled phase, adverse events were reported in 54/64 (84 per cent) patients who took REMINYL® and 41/66 (62 per cent) who took placebo. The most common adverse events in the REMINYL® group were nausea (23.4 per cent), vomiting (17.2 per cent) and upper respiratory tract infection (12.5 per cent). Serious adverse events were reported in 5/64 patients on REMINYL®, and 10/66 on placebo after four months. In the open-label phase, 47/54 patients newly receiving REMINYL® reported adverse events; there were no serious adverse events. Of those already on REMINYL®, serious adverse events were reported in four patients.9

The VISTA trial was a peer-reviewed, investigator initiated trial funded by Janssen-Ortho Inc. and the Canadian Institutes of Health Research.

About Alzheimer's Disease

Alzheimer's disease is a progressive disease of the brain that is most common among people over age 65. Various cognitive and behavioural symptoms emerge at different stages of the disease.10 Since it is progressive, these symptoms usually worsen as the brain continues to deteriorate.

Approximately 300,000 Canadians over the age of 65 have Alzheimer's disease.11 There is no cure for Alzheimer's disease, but prescription medications like REMINYL® can reduce the progression of behavioural, cognitive and functional symptoms, and reduce caregiver distress.12,6

About REMINYL®

In clinical trials of over 2,600 patients, those treated with REMINYL® showed significant improvements in cognitive, functional and behavioural symptoms.12,13,14,15 Data published in the American Journal of Psychiatry in 2004 shows that treatment with REMINYL® may reduce specific behavioural symptoms in patients with mild to moderate Alzheimer disease. The study also tracked caregiver distress and found a significant reduction.6

In 2005, Health Canada approved REMINYL® ER (galantamine HBr extended release capsules), a once-daily formulation of REMINYL®. REMINYL® and REMINYL® ER are indicated for the symptomatic treatment of mild to moderate Alzheimer's disease. The most frequent adverse events are nausea, vomiting, diarrhea, anorexia and weight loss. They are usually mild and temporary.

Janssen-Ortho Inc.

Janssen-Ortho Inc. is a brand-name pharmaceutical company headquartered in Toronto with a broad range of medications used in psychiatry, neurology, dementia, attention deficit hyperactivity disorder, pain management, women's health, infectious disease, gastroenterology, and urology.

References

1 - Rockwood K, Fay S, Jarrett P, Asp E. Effect of galantamine on verbal repetition in AD: a secondary analysis of the VISTA trial. Neurology. 2007;68:1116-1122.

2 - Cullen B, et al. Repetitive behaviour in Alzheimer's disease: description, correlates and functions. Int J Geriatr Psychiatry. 2005;25:686-693.

3 - Asp E, et al. Verbal repetition in patients with Alzheimer's disease who receive donepezil. Int J Geriatr Psychiatry. 2006;21:426-431.

4 - Bourgeois M, Burgio L, Schulz R, Beach S, Palmer B. Modifying Repetitive Verbalizations of Community-Dwelling Patients with AD. Gerontologist. 1997;37(1):30-39.

5 - Gauthier SG. Alzheimer's disease: the benefits of early treatment. Eur J Neurol. 2005 Oct;12 Suppl 3:11-16.

6 - Cummings JL., Reduction of behavioural disturbances and caregiver distress by galantamine in patients with Alzheimer's Disease. Am J Psychiatry. 2004;161(3):532-538.

7 - A national online survey of 398 caregivers who provide paid or unpaid care to someone who has (or is suspected of having) Alzheimer's disease or related dementia was conducted by Decima Research between September 15, 2005 and November 5, 2005. The survey was sponsored by Janssen-Ortho Inc.

8 - Hwang JP, Tsai SJ, Yang CH, Liu KM, Lirng JF. Repetitive phenomena in dementia. Int J Psychiatry Med. 2000;30(2):165-171.

9 - Rockwood K, et al. Attainment of treatment goals by people with Alzheimer's disease receiving galantamine: a randomized controlled trial. CMAJ. 2006 Apr 11;174(8):1009-1105.

10 - Bouchard RW, Rossor MN. Typical clinical features. In: GauthierS editor. Clinical Diagnosis and Management of Alzheimer's Disease. 2ed. London: Martin Dunitz; 2001. p.57-71.

11 - Alzheimer Society of Canada. Based on projected estimates in the following study: The Canadian Study of Health and Aging Working Group. Canadian Study of Health and Aging: study methods and prevalence of dementia. CMAJ. 1994; 150(6): 899-913. Available at http://www.alzheimer.ca/english/disease/stats-people.htm (Accessed March 6, 2007).

12 - Tariot PN., et al. A five-month, randomized, placebo-controlled trial of galantamine in AD. Neurology. 2000;54:2270-2276.

13 - Raskind MA., et al. Galantamine in AD a 6-month randomized, placebo-controlled trial with a six-month extension. Neurology. 2000;54:2261-2268.

14 - Wilcock GK., et al. Efficacy and safety of galantamine in patients with mild to moderate Alzheimer's disease: mulitcentre randomized controlled trial. BMJ. 2000;321:1-7.

15 - Rockwood et al. Effects of a flexible galantamine dose in Alzheimer's disease: a randomized, controlled trial. J Neurol Neurosurg Psychiatry. 2001;71:589-595.

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