Effect of ispronicline, a neuronal nicotinic acetylcholine receptor partial agonist, in subjects with age associated memory impairment (AAMI)
Abstract
Cognitive decline seen in the normal elderly is associated with selective loss of neuronal nicotinic acetylcholine receptors (nAChRs). Nicotine given either by inhalation or transdermally helps cognition, but unacceptable side effects limit its utility. The present study assessed the safety, tolerability and effect on cognition of ispronicline, a highly selective partial agonist at the 4β2 nAChR, in elderly subjects ( n =76) with age associated memory impairment (AAMI). This double-blind, placebo-controlled cross-over study explored ascending oral doses of ispronicline in the range 50–150mg given as a single morning dose for a period of 3 weeks. Pharmacokinetics (PK) were assessed, as well as cognitive function measured by means of the Cognitive Drug Research (CDR) computerized test battery. Ispronicline had a favourable safety profile and was well tolerated at doses below 150mg. No effect of clinical importance was seen on biochemistry, haematology, urine analysis, vital signs, electrocardiogram (ECG) or Holter monitoring. The most frequent drug induced adverse event was light-headedness (dizziness). A beneficial effect was seen on cognition across the dose range. This was most marked at 50mg on factors measuring attention and episodic memory. PK analysis indicated a plasma Cmax range of 5–25/35ng/ml ispronicline was associated with the most beneficial effect. These early results demonstrate ispronicline was well tolerated and did not display the side effects typical of nicotine. Ispronicline also had a beneficial effect on cognition in subjects with AAMI. This was seen most strongly in a Cmax range that had been predicted from pre-clinical animal studies.
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Some evidence supports the view that α4β2* nAChR compounds may be useful for treating the cognitive symptoms of ADHD, schizophrenia and aging.
“Although the clinical evidence remains limited, some evidence supports the view that such compounds may be useful for treating the cognitive symptoms of ADHD, schizophrenia and aging (Dunbar et al, 2007; Wilens et al, 1999, 2006; Wilens and Decker, 2007; Potter et al, 1999).”
From Modes and models of forebrain cholinergic neuromodulation of cognition (2011) · cites this paper as Dunbar et al, 2007
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- Authors
- Dunbar, G. C., Inglis, F., Kuchibhatla, R., Sharma, T., Tomlinson, M., & Wamsley, J.
- Affiliations
- Clinical Development and Regulatory Affairs, Targacept Inc., Winston Salem, USA
- Golden Jubilee National Hospital (GB)
- Clinical Neuroscience Research Centre, Dartford, UK
- Sequani Clinical, Ledbury, UK
- Venue
- Journal of Psychopharmacology
- Publisher
- SAGE Publications
- Published
- 2007-03
- Volume
- 21
- Issue
- 2
- Pages
- 171-178
- ISSN
- 0269-8811 (ISSN-L)
- 1461-7285
- OpenAlex
- W2075996484
- Cited by
- 75
- References
- 16
- Citations by year
- 2026: 1 · 2023: 1 · 2022: 2 · 2021: 2 · 2020: 2 · 2019: 1 · 2018: 3 · 2017: 2 · 2016: 2 · 2015: 2 · 2014: 7 · 2013: 7 · 2012: 8
- FWCI
- 4.09
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Journal of Psychopharmacology (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Nicotinic Acetylcholine Receptors Study
- Health Sciences › Medicine › Psychiatry and Mental health › Dementia and Cognitive Impairment Research
- Health Sciences › Medicine › Physiology › Smoking Behavior and Cessation
- Keywords
- neuronal nicotinic acetylcholine receptors, partial agonists, age-associated memory impairment, cognitive decline in older adults, pharmacokinetics, dose-response relationship, attention, episodic memory, drug safety and tolerability, Cmax
- MeSH terms
- Aged, Cognition, Dizziness, Dose-Response Relationship, Drug, Double-Blind Method, Electrocardiography, Female, Humans, Male, Memory Disorders, Middle Aged, Pyridines, Receptors, Nicotinic, Cross-Over Studies, Nicotinic Agonists
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