An Enriched-Population, Double-Blind, Placebo-Controlled, Crossover Study of Tacrine and Lecithin in Alzheimer's Disease

Foster, Norman L.; Petersen, R.; Gracon, Stephen I.; Lewis, Karen W.

doi:10.1159/000106890

Cited by 9 publications

(6 citation statements)

References 14 publications

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“…No differences before and after treatment with THA were present in patients with reference to MMSE and ADL scores, showing that this drug produces no clinically relevant improvement. Similar results have been achieved in the remaining studies examined [16][17][18].…”

Section: Resultssupporting

confidence: 87%

Tacrine Treatment of Alzheimer’s Disease: Many Expectations,Few Certainties

Malaguarnera

Pistone²,

Vinci³

et al. 1998

Neuropsychobiology

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Quality of life and behavioral functions are severely reduced in patients affected by Alzheimer’s disease (AD). Among the drugs employed in the treatment of this invalidating degenerative dementia, tacrine (THA) seemed to play a possible therapeutic role. Our study was aimed to evaluate the efficacy of THA in the treatment of AD, performing a comparison with lecithin and/or placebo treatment. Five randomized controlled trials on tacrine versus lecithin and/or placebo treatment were randomly selected. Mantel-Haenszel-Peto method was applied. Patients treated with tacrine achieved better results than control subjects (overall OR = 2.34; 95% CI 1.42–3.85); but long-term treatment with tacrine was not significantly more efficacious than placebo. Statistical significance in favor of THA versus other drugs employed was obtained in MMSE and ADAS-Cog tests in the studies carried out by Eagger et al. and Knapp et al. Moreover, Fitten et al. administered the highest tolerated THA dose to only a few patients enrolled in the study. The presence of broad CIs observed in the 5 meta-analytic studies infer non homogeneity of effects of treatment. Solely few patients improved, whereas the clinical conditions of the majority remained stationary. Between 5 and 10% of the outpatients in each single study presented reversible side effects calling for suspension of THA treatment. The optimal dose ranged between 80 and 160 mg THA, but often produced side effects. Comparative trials revealed the reduced efficacy and elevated toxicity of THA treatment, dampening the initial enthusiasm concerning the usefulness of this drug in AD. Furtermore, tacrine-induced side effects provoked many dropouts in all studies investigated. The effectiveness of tacrine treatment in AD disease was not fully confirmed. Other studies are required to identify doses and modalities of administration of this drug in AD.

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Section: Resultssupporting

confidence: 87%

Tacrine Treatment of Alzheimer’s Disease: Many Expectations,Few Certainties

Malaguarnera

Pistone²,

Vinci³

et al. 1998

Neuropsychobiology

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“…26 Both medications have been extensively studied. [27][28][29][30][31][32][33][34] Tacrine showed a modest cognitive improvement in up to 30 percent of patients who were able to tolerate the medication. The efficacy and side effects of Donepezil has been reported in three clinical trials.…”

Section: Resultsmentioning

confidence: 99%

Donepezil (Aricept®) treatment of multi infarct dementia: The caregivers and clinical impression

Shua-Haim

Comsti³

et al. 2000

American Journal of Alzheimer's Disease

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The purpose of this study was to investigate the clinical and caregivers impression of Aricept ® treatment in patients suffering from Multi-Infarct Dementia (MID).In a prospective study 73 MID patients 1 were treated with Donepezil (Aricept ® ) for 16-to 20-weeks. Donepezil was administered as a 5mg tablet once daily at bedtime. After four weeks, patients tolerant of the 5-mg dose were increased to 10 mg daily. All patients satisfied the DSM-III-R criteria for Multi-Infarct Dementia. 2 After 16-to 20-weeks of treatment, the patient's caregiver completed a questionnaire concerning the effectiveness of the drug. Subjective cognitive improvement, MMSE, 3 ADL 4 and IADL 5 outcomes were all assessed before and after treatment (referred to as Clinical Impression). Behavioral outcomes evaluated included depression, agitation, violence, anxiety, and paranoid thoughts.Functional and overall family satisfaction were also evaluated. Side effects as well as reasons for discontinuation from the study were also reported.Seventy-three patients participated in the study. Twelve patients (16 percent) terminated participation due to side effects. Total adverse events were reported in 34 (46.5 percent) of patients. Cognitive improvement was reported in 31 (42.4 percent) patients. Verbal skills and attention were the most commonly reported cognitive improvement. Average MMSE declined by 2.6 points after 16-weeks of treatment. No behavioral improvement was reported. Behavioral deterioration was reported in 16 (21.9 percent) of patients. Functional improvement was reported in 32 (42.8 percent) patients. Overall positive family satisfaction was reported in 54 (73.9 percent) patients.Although Donepezil treatment was approved by the FDA for the treatment of Alzheimer's Disease (AD), such treatment for MID patients appears to be a reasonably safe and effective treatment from the caregiver and family's point of view.

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“…Phosphatidylcholine (PC) is a large precursor pool of choline available for use in acetylcholine synthesis [8]. While there are several reports of improved memory function in animals [9,10], the results from the administration of PC to patients with Alzheimer's disease are negative [11][12][13]. This may be due to the different conditions under which the studies were conducted, the intake period, and the amounts and origin of PC.…”

Section: Introductionmentioning

confidence: 99%

Dose-Response Effect of Egg-Phosphatidylcholine on Maze-Learning Ability and Fatty Acid Composition of Plasma and Brain in Aged Mice Fed an n–3 Fatty Acid-Deficient Diet

Lim¹,

Suzuki²

2002

Ann Nutr Metab

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Background/Aims: We investigated the dose-response effect of egg-phosphatidylcholine (PC) on the maze-learning ability and brain fatty acid composition in aged mice. Method: Male Crj:CD-1 mice aged 18 months were fed the following diets for 4 months: (i) 5 g palm oil/100 g diet (n–3-deficient control group); (ii) 1 g egg-PC/100 g diet plus 4 g palm oil/100 g diet (egg-PC 1% group); (iii) 2.5 g egg-PC/100 g diet plus 2.5 g palm oil/100 g diet (egg-PC 2.5% group), and (iv) 5 g egg-PC/100 g diet (egg-PC 5% group). Maze-learning ability was assessed 3 months after the start of the experiment. All animals were maintained on the n–3 fatty acid-deficient diets to examine the direct effect of egg-PC on maze behavior. The time required to reach the maze exit and the number of times that a mouse strayed into blind alleys in the maze were measured in 3 trials every 4 days. Results: Our results showed that the 2.5 and 5% egg-PC groups needed less (p < 0.05) time to find the exit and strayed into blind alleys fewer times (p < 0.05) than the control group. In order to determine the relationship between maze-behavior and brain docosahexaenoic acid (DHA) and arachidonic acid (AA) levels in aged mice fed various doses of egg-PC, the plasma and brain fatty acid composition was examined. Dose-response increases in the percentage of DHA were found in plasma lipids. However, based on our data on the brain fatty acid composition of mice fed various doses of egg-PC, no significant differences in the percentages of DHA and AA among the dietary groups were observed. Conclusion: These results suggest that the intake of egg-PC improves maze-learning ability in aged mice fed n–3 fatty acid-deficient diets but it does not influence the percentage of brain DHA and AA.

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An Enriched-Population, Double-Blind, Placebo-Controlled, Crossover Study of Tacrine and Lecithin in Alzheimer's Disease

Cited by 9 publications

References 14 publications

Tacrine Treatment of Alzheimer’s Disease: Many Expectations,Few Certainties

Tacrine Treatment of Alzheimer’s Disease: Many Expectations,Few Certainties

Donepezil (Aricept®) treatment of multi infarct dementia: The caregivers and clinical impression

Dose-Response Effect of Egg-Phosphatidylcholine on Maze-Learning Ability and Fatty Acid Composition of Plasma and Brain in Aged Mice Fed an n–3 Fatty Acid-Deficient Diet

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