The article below is extracted from Medical Tribune dated 15 - 31 Dec 2006. You can download the issue from Medical Tribune website at http://www.medicaltribune.com/
GuidAge™ - An Alzheimer’s Disease Prevention Clinical Study
by Professor Bruno Vellas, MDChairman of EADC (European Alzheimer’s Disease Consortium)
Chief of Department of Internal Medicine and Geriatrics
Professor of Medicine, University Hospital Center
Toulouse, France
The GuidAge™ trial is a secondary prevention study looking at the prevention of Alzheimer’s disease (AD) in Europe. This randomized, placebo-controlled, double-blind phase III study involves elderly patients aged 70 years and above, who reported a spontaneous memory complaint to their general practitioner. The study aims at assessing the efficacy of EGb 761® on the frequency and the delay of onset of Alzheimer-type dementia over a period of 5 years.
Study rationale
Studies have shown that elderly subjects with memory complaints are at increased risk to develop dementia or AD, even though cognitive impairment is not yet apparent. 1,2 These patients constitute a good target population to assess the effects of prevention. Findings from EPIDOS3 suggest that treatment with EGb 761® (for at least 3 years) is associated with a lower incidence of dementia.
Study Protocol
Patients are first validated in a specialized memory centre for inclusion into the study by a comprehensive neurological examination, including Lawton’s instrumental activities of daily living (IADL) functional assessment, and criteria for dementia (CDR). Patients are randomized to receive either placebo or EGb 761® at a daily dose of 240mg (120 mg bid).
General practitioners follow up patients every 3 months. Patients with suspected dementia are referred to the memory centre. During follow-up, patients whose cognitive functions are not altered are presented annually to the memory centre, where all the tests the tests for dementia screening (eg: Cognitive Difficulty Scale [CDS/McNair items]. CDR, Grober and Buschke test) are carried out. Depression using the Geriatric Depression Scale (GDS) is also assessed once a year by general practitioners.
Overall analysis of recruited patients
The results obtained from the Grober and Buschke test (ie free and cued selective reminding test) confirmed that the patients did not have AD at study baseline.
On average, the CDS scores (reflective of cognitive complaint) reached 24.1 and 28.5 in patients with a CDR = 0 and CDR = 0.5, respectively (P<0.001). Table 1 shows the most frequent cognitive complaints (McNair items) in patients with CDR = 0 and CDR = 0.5.
Individuals with an IADL score ≥1 report a cognitive complaint more often than those with an IADL score of 0, and this usually correlates with a CDR of 0.5. Of the patients followed up for a year, 49 developed Alzheimer’s dementia while 10 developed dementia of other types.
According to the study protocol, the last patients will be treated until 2009, and the results will be available in 2010.
References:
1. Geerlings MI, et al. Am J Psychiatry 1999;531-537.
2. Dartigues JF, et al. Therapie 1997;52:503-506.
3. Andrieu S, et al. J Gerontol A Biol Sci Med Sci 2003;58A:372-377.
