Clinical trial

The Nicotinic Cholinergic System and Cognitive Aging

Name
CHRMS 16-284
Description
Prior research has shown that a chemical system in the brain called the cholinergic system is primarily responsible for cognitive symptoms seen in people with dementia. While therapeutic benefits are clear in dementia, what remains uncertain is the role that the cholinergic system in general and a subset of receptors called the nicotinic system plays in cognition in healthy non-demented older adults (referred to as normal cognitive aging). This is critical because the ever growing healthy aging population will show declines in cognition that fall short of dementia but still impact functional abilities and independence. Maintaining good nicotinic system functioning throughout adulthood may lessen the cognitive symptoms of aging. At this time, it is not clear what the biological cause of age-related changes in cognition is. This study will examine the role of the nicotinic system in the healthy aging brain and examine its role in memory and thinking processes in older and younger adults.
Trial arms
Trial start
2016-10-01
Estimated PCD
2021-12-01
Trial end
2022-01-31
Status
Completed
Phase
Early phase I
Treatment
Nicotine patch, oral mecamylamine, placebo
Each participant randomly receives one active drug or placebo on each of three study days.
Arms:
Older Adults, Younger Adults
Size
104
Primary endpoint
Age effects of nicotinic blockade
After the completion of the third study day.
Age effects of nicotinic stimulation
After the completion of the third study day.
Eligibility criteria
Inclusion Criteria: * Normal cognition, not demented, no mild cognitive impairment. IQ greater than 80. Exclusion Criteria: * Current use of barbiturates, rifampin, insulin, carbamezepine, oral hypoglycemics, antidepressants, diabetes, or untreated thyroid disease. * In addition, the following exclusions are specific for the challenge drugs: heavy alcohol or coffee use, significant cardiovascular disease, ischemic heart disease, asthma, chronic obstructive pulmonary disease, active peptic ulcer, hyperthyroidism, pyloric stenosis, narrow angle glaucoma, epilepsy, or current Axis I psychiatric disorders. * Current use of centrally active drugs and drugs with cholinergic properties. A minimum of 14 days will elapse between discontinuing centrally active or psychoactive agents and this study.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Healthy older adults aged 65-75 and healthy younger adults aged 18-30 will be recruited. Each participant will take part in 3 nicotinic drug challenge days. The three drugs are counterbalanced across study days within each group and balanced by sex.', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': 'This is a double blind study. The PI and all study personnel are blinded. Only the pharmacist dispensing the medication and the biostatistician who created the counterbalancing order are unblended.', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 104, 'type': 'ACTUAL'}}
Updated at
2023-05-09

1 organization

1 product

1 indication

Indication
Healthy Aging