Method of treating benign forgetfulness

Details Method of treating benign forgetfulness Method of treating benign forgetfulness

2000-11-02

2002-01-01

Henley, III, Raymond (Department: 1614)

Drug, bio-affecting and body treating compositions

Designated organic active ingredient containing

Having -c-, wherein x is chalcogen, bonded directly to...

C514S556000, C514S565000, C514S689000

Reexamination Certificate

active

06335361

ABSTRACT:

TECHNICAL FIELD
This invention is related to the prevention and amelioration of memory deficits related to aging and other causes. More specifically, this invention is related to the administration of micronutrients, such as an antioxidant, a canitine product, and optionally coenzyme Q and/or creatine to those at risk of memory loss.
BACKGROUND OF INVENTION
Many adults gradually develop noticeable difficulties in memory, at first for names, then for events, and sometimes even occasionally for spatial relationships. The majority of healthy older people complain about forgetfulness and decreased concentration, and this compromises their quality of life. It is well established that virtually all aspects of cognitive functioning deteriorate with age. There has also been a rapid increase in the interest of clinicians, researchers and the pharmaceutical industry in the development of new classes of drugs for the palliative treatment of age-related cognitive deficits and dementing conditions. This widely experienced so-called benign forgetfulness, or benign senescent forgetfulness, bears no proven relationship to degenerative dementia but may be a forewarning, since there are some similarities.
Kral was the first to introduce diagnostic terminology for age-associated changes in memory (J Gerontol 13: 169-176, 1958; Can Med Assoc J 86: 257-260, 1962). He used the term “benign senescent forgetfulness” (BSF) to distinguish subjects with mild memory decline from those with more severe, “malignant” changes (MSF), and also from those with normal memory functions.
Since then BSF and MSF have often been used in the medical literature and have become a generally accepted notion among clinicians. Generally, BSF is characterized by patchy and variable difficulties remembering details of experiences (names and places), but with relative ease in recalling the experience itself. Usually the forgotten details are recalled later. BSF is not progressive and does not increase the risk of developing dementia. MSF is characterized by an inability of the individual to recall events in the recent past, disorientation with regard to personal data, and retrogressive loss of remote memories. MSF individuals often are unaware of their deficit and may confabulate. In a four-year study of 20 cases of BSF and 34 of MSF, one patient with BSF deteriorated cognitively and all MSF patients deteriorated. A recent three-year study of 68 BSF patients reported that 9% became demented.
Because Kral did not operationalize the concept of BSF, a National Institute of Mental Health (NIMH) working group, which was set up to describe memory changes more precisely, proposed the concept of “age-associated memory impairment” (AAMI) as a diagnostic entity (Crook et al. 1986, ibid.). In brief, the criteria of AAMI include the presence of subjective memory decline, objective evidence of memory loss (in a well-standardized memory test, a score at least one standard deviation below the mean of younger adults), adequate intellectual function, and the absence of dementia or other memory-affecting disease (e.g. stroke) in a person aged 50 years or older. Thus, the AAMI diagnosis identifies persons with subjectively and objectively evidenced memory loss without cognitive decline impairing enough to warrant the diagnosis of dementia. The criteria leave open the question of progression in the condition.
McEntee and Crook (Neurology 40: 526-530, 1990) estimated that AAMI might affect most of the over-50 population to some degree. However, Lane and Snowdon (Memory and dementia: A longitudinal survey of suburban elderly. In: Lovibond P, Wilson P (eds). Clinical and abnormal psychology. Elsevier, Amsterdam, 365-376, 1989) reported a prevalence rate of 35% for AAMI in subjects aged 65 years or over. The results are somewhat hampered by the low participation rate (58%) of the study population, and by the fact that the methodology used did not strictly follow the definitions of the NIMH working group. On the basis of memory test performance alone, Larrabee and Crook (Int Psychogeriatr 6: 95-104, 1994) estimated the prevalence of AAMI to vary from 39% in the age group 50 to 59 years to 85% in the age group over 80 years. In that study, no exclusion criteria were employed. Barker et al. (Br J Psychiatry 167: 642-648, 1995) identified as many as 79% of the participants in the AAMI category by memory test results. However, after applying stringent exclusion criteria, they reported a 15.8% prevalence of AAMI in 50- to 64-year-old and 24.1% in 65- to 79-year-old subjects.
A task force of the International Psychogeriatric Association (IPA) in collaboration with the World Health Organization (WHO) recently proposed diagnostic criteria for “aging-associated cognitive decline” (AACD) (Levy, Int Psychogeriatr 6: 63-68, 1994). The diagnosis of AACD is based on a more comprehensive evaluation of cognition than that of AAMI. Deterioration in any major cognitive domain is sufficient for identifying AACD. The cognitive domains specified in the AACD criteria are memory and leaming, attention and concentration, thinking, language and visuospatial functioning. Also differing from the AAMI criteria, the subject with AACD is required to score one standard deviation below age- and education-specific standards (not those of younger adults) in tests assessing cognitive abilities. Thus, the AACD diagnosis identifies persons with subjective and objective cognitive decline, which is not impairing enough to warrant the diagnosis of dementia. In presenting the AACD criteria, the task force recognized the individual in progression or not to dementia.
AAMI may start in middle age (around the age of 40 years), as measured by some categories of cognitive tests. Age-related cognitive problems may lie dormant for decades and only become gradually or suddenly apparent as the individual realizes that some aspect of functioning is no longer what it used to be. Some propose that gradual cognitive decline may be due to accumulation of minor brain insults, such as falls from which an individual appears to completely recover. At first, these minor pathologies may have little impact but, as they accumulate with advancing age, their amassed effects result in discernible cognitive deficits. A decline in sensory, perceptual and physical performance can greatly impact general cognitive functions, even without direct or causal relation to cognitive performance. “Executive function” appears an important mediator of age-related dysfunction, as it has been shown that after correction for executive function, age was not a predictor for test performance.
Because of the high rate of memory impairment, AAMI is likely to be a phenomenon of normal aging rather than a continuum from normal aging to a pathologic state such as Alzheimer's disease. The neuropsychological methods used for AAMI diagnosis are ambiguous and do not always differentiate subjects with very early dementia. However, these subjects can be differentiated by means of a more detailed neuropsychological evaluation. In comparison with age-matched controls, AAMI subjects appeared to be impaired not only in tests assessing memory, but also in tests of the executive finctions associated with frontal lobe finction. This finding agrees with previous reports suggesting an important role for frontal lobe dysflnction in the memory loss of elderly people. Comparing subjects with high and low frequencies of subjective complaints of memory loss suggested that these subjective feelings of memory impairment are more closely associated with personality traits than with actual memory performance in normal elderly people. This complicates the use of memory complaints in the inclusion criteria for AAMI and AACD diagnosis.
The prevalence of AACD has been found to be lower than that of AAMI. As AAMI tends to identify a very heterogeneous subject group, the AACD diagnosis might prove superior to AAMI for differentiating a meaningful subgroup from the elderly population, both for research purposes and in clinical settings. This remains to be confirmed i

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