Safety, pharmacokinetics, and effects on cognitive function of multiple doses of GTS-21 in healthy, male volunteers

Neuropsychopharmacology

Volumn 28, Issue 3, 2003, Pages 542-551

  Kitagawa, Harumi ^a   Takenouchi, Toshiharu ^b   Azuma, Ryotaro ^b   Wesnes, Keith A ^c   Kramer, William G ^d   Clody, Donald E ^a   Burnett, Angela L ^a  

^a IQVIA   (United States)

^b TAIHO PHARMACEUTICAL CO LTD   (Japan)

^c Cognitive Drug Research ^*  (United Kingdom)

^d Kramer Consulting LLC   (United States)

Author keywords

Alzheimer s disease; Cognition disorder; Pharmacokinetics

Indexed keywords

3 (2,4 DIMETHOXYBENZYLIDENE)ANABASEINE; 3-(2,4-DIMETHOXYBENZYLIDENE)ANABASEINE; BENZYLIDENE DERIVATIVE; PYRIDINE DERIVATIVE;

ADOLESCENT; ADULT; ANALYSIS OF VARIANCE; AREA UNDER THE CURVE; ARTICLE; CHEMISTRY; CLINICAL TRIAL; COGNITION; COMPARATIVE STUDY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG EFFECT; HUMAN; LIVER; MALE; METABOLISM; MIDDLE AGED; PHYSIOLOGY; RANDOMIZED CONTROLLED TRIAL;

ADOLESCENT; ADULT; ANALYSIS OF VARIANCE; AREA UNDER CURVE; BENZYLIDENE COMPOUNDS; COGNITION; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; HUMANS; LIVER; MALE; MIDDLE AGED; PYRIDINES;

EID: 0038690569     PISSN: 0893133X     EISSN: 1740634X     Source Type: Journal    
DOI: 10.1038/sj.npp.1300028     Document Type: Article

References (16)

1. Azuma R, Minami Y, Satoh T (1996). Simultaneous determination of GTS-21 and its metabolite in rat plasma by high-performance liquid chromatography using solid-phase extraction. J Chroma-togr B Biomed Appl 686: 229-234.
2. Bartus RT, Dean RL, Beer B, Lippa AS (1982).The cholinergic hypothesis of geriatric memory dysfunction. Science 217: 408-414.
3. Bond A, Lader M (1974). The use of analogue scales in rating subjective feelings. Br J Med Psychol 47: 211-218.
4. Francis PT, Palmer AM, Sims NR, Bowen DM, Davison AN, Esiri MM et al (1985). Neurochemical studies of early-onset alzheimer’s disease. Possible influence on treatment. N Engl J Med 313: 7-11.
5. Mayeux R, Schofield PW (1994). Alzheimer’s disease. In: Hazzard WR, Bierman EL, Blass JP, Ettinger WH, Halter JB (eds). Principles of Geriatric Medicine and Gerontology, 3rd edn. McGraw Hill: New York, 1035-1050.
6. Merz M, Seiberling M, Höxter G, Hölting M, Wortha HP (1997). Elevation of liver enzymes in multiple dose trials during placebo treatment: are they predictable? J ClinPharmacol 37: 791-798.
7. Parrott A, Garnham N, Wesnes K, Pincock P (1996). Cigarette smoking and abstinence: comparative effects upon cognitive task performance and mood state over 24hours. Hum Psychophar-macol 11: 391-400.
8. Perry EK, Tomlinson BE, Blessed G, Bergmann K, Gibson PH, Perry RH (1978). Correlation of cholinergic abnormalities with senile plaques and mental test scores in senile dementia. BMJ 2: 1457-1459.
9. Purkins L, Eve MD, Love ER, Smith C, Cowen C (1997). The effect of diet on selected liver function tests. Eur J ClinPharmacol 52: A115.
10. Rosenzweig P, Miget N, Brohier S (1999). Transaminase elevation on placebo during Phase I trials: prevalence and significance. Br J ClinPharmacol 48: 19-23.
11. Schroder H, Giacobini E, Struble RG, Zilles K, Maelicke A (1991). Nicotinic cholinoceptive neurons of the frontal cortex are reduced in Alzheimer’s disease. Neurobiol Aging 12: 259-262.
12. Strock M (1994). Alzheimer’s Disease. Information Resources and Inquiries Branch, Office of Scientific Information, National Institute of Mental Health (NIMH). NIH Publication No. 943-676. NIH: Washington, DC.
13. vanHarten J, Olff M, Wesnes K, Strobel W (1996). Flesinoxan improves cognition in the elderly. EurNeuropsychopharmacol 6(Suppl 3): 186.
14. Wesnes K, Simpson PM, Kidd AG (1988). An investigation of the range of cognitive impairments induced by scopolamine 0.6 mg. Hum Psychopharmacol 3: 27-41.
15. Wesnes K, Warburton DM (1984). Effects of scopolamine and nicotine on human rapid information processing performance. Psychopharmacology 82: 147-150.
16. Whitehouse PJ, Martino AM, Antuono PG, Lowenstein PR, Coyle JT, Price DL et al (1986). Nicotinic acetylcholine binding sites in Alzheimer’s disease. Brain Res 371: 146-151.