Age-Related Memory DisordersPhase 1NCT00091468
Nicotine Treatment of Mild Cognitive Impairment (MCI)
A Phase 1 study testing Transdermal nicotine patch in people with Age-Related Memory Disorders, run by National Institute on Aging (NIA) at 3 sites in United States.
Trial summary
The purpose of this 12-month study is to determine whether nicotine, administered in the form of nicotine patches, can improve symptoms of memory loss in some people experiencing mild memory problems (referred to in this study as "mild cognitive impairment" or MCI). Read more about this study
- Who is it for?
- Ages 55 to 90 years
- Conditions the study is for
- Age-Related Memory Disorders
- What is being tested?
- Transdermal nicotine patch
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2003to Jul 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Any significant neurologic disease such as Alzheimer's disease, Parkinson's disease, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic deficits or known structural brain abnormalities.
- Major depression or another major psychiatric disorder as described in DSM-IV within the past 2 years.
- History of alcohol or substance abuse or dependence within the past 2 years (DSM IV criteria).
- Any significant, unstable medical condition.
- Use of any investigational drugs within 30 days or 5 half-lives, whichever is longer, prior to screening.
- Any tobacco use within the past year.
- Exceptions to these specific Inclusion and Exclusion Criteria (e.g., WMS-R cutoffs) may be made on a case by case basis by the Principal Investigator.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Vermont College of Medicine
Burlington, Vermont, 05401
Duke University, Duke Health Center at Morreene Road
Durham, North Carolina, 27705
Georgetown University Medical Center, Department of Neurology
Washington D.C., District of Columbia, 20057
About this study
Official title: Double-Blind Treatment of Mild Cognitive Impairment (MCI) With Transdermal Nicotine or Transdermal Placebo
The purpose of this 12-month study is to determine whether nicotine, administered in the form of nicotine patches, can improve symptoms of memory loss in some people experiencing mild memory problems (referred to in this study as "mild cognitive impairment" or MCI).
Read the detailed description
The purpose of this study is to determine whether nicotine can improve symptoms of memory loss in some people experiencing mild memory problems (referred to in this study as "mild cognitive impairment" or MCI). The study will last approximately 12 months and will be conducted at 3 clinical sites in the United States.
Recent studies have suggested that one of the causes of memory disorders may be a reduction in a particular chemical substance in the brain. This chemical substance, acetylcholine, is thought to act on certain brain cells in a specific way that helps us to remember and use memories as well as affect our mood. In MCI (and Alzheimer's disease), the level of acetylcholine may be changed, and this may impair brain functioning. Preliminary studies have suggested that short-term administration of nicotine appears to improve memory in patients with mild memory loss and early Alzheimer's disease. Nicotine imitates many of the actions of acetylcholine. By administering nicotine over a longer period of time to patients with MCI, this study could lead to a better understanding of whether nicotine can act to improve memory loss symptoms over the longer term and whether it can help delay the progression of memory loss symptoms. The amount of nicotine in each patch used in this study is the same level found in patches that are used in people who are trying to quit smoking.
This study will include up to twelve visits.
- Conditions
- Age-Related Memory Disorders
- Being tested
- Transdermal nicotine patch, Placebo transdermal patch
- Keywords
- Age-Related Memory Loss, Nicotine, Mild Cognitive Impairment (MCI)
- Medical subject headings
- Memory Disorders, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transdermal nicotine patchDrug
Also called Nicotrol
double-blind phase: 5mg for 1 week, 10mg for 2 weeks, 15mg for 23 weeks open label phase: 5mg for 1 week, 10mg. for 2 weeks, 15mg. for 23 weeks taper down: 10mg. for 2 weeks, 5mg. for 1 week
Placebo transdermal patchDrug
placebo patch, 5mg for 1 week, 10mg for 2 weeks, 15mg for 23 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo Group | Placebo comparator | Placebo for first six months of study; moved to open-label active nicotine for second six months Receives: Drug: Placebo transdermal patch |
| Active Nicotine Group | Experimental | Blinded active nicotine for first six months of study; open-label active nicotine for second six months Receives: Drug: Transdermal nicotine patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of transdermal nicotine patch
Measured: 13 months
Secondary outcomes (2)
Change in cognitive performance
Measured: 13 months
Change in global functioning
Measured: 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2004 (estimated)
- Study startSep 2003
- Primary completionJul 2008 (estimated)
- Study completionJul 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Age-Related Memory DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute on Aging (NIA)
- Sponsor type
- US National Institutes of Health
- Investigators
- Paul Newhouse, MD, Principal investigator, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00091468
- Sponsor's protocol ID
- IA0060
- Other IDs
- R01AG022462-02
- Status last verified
- Jan 2008
- First submitted
- 9 Sep 2004
- Last updated
- 15 Jan 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Newhouse PA, Potter A, Singh A. Effects of nicotinic stimulation on cognitive performance. Curr Opin Pharmacol. 2004 Feb;4(1):36-46. doi: 10.1016/j.coph.2003.11.001.
PubMed 15018837Newhouse P, Singh A, Potter A. Nicotine and nicotinic receptor involvement in neuropsychiatric disorders. Curr Top Med Chem. 2004;4(3):267-82. doi: 10.2174/1568026043451401.
PubMed 14754447Newhouse PA, Potter A, Kelton M, Corwin J. Nicotinic treatment of Alzheimer's disease. Biol Psychiatry. 2001 Feb 1;49(3):268-78. doi: 10.1016/s0006-3223(00)01069-6. No abstract available.
PubMed 11230878
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind Treatment of Mild Cognitive Impairment (MCI) With Transdermal Nicotine or Transdermal Placebo
- ClinicalTrials.gov ID
- NCT00091468
- Acronym / sponsor ID
- IA0060
- Conditions
- Age-Related Memory Disorders
- Keywords
- Age-Related Memory Loss, Nicotine, Mild Cognitive Impairment (MCI)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- National Institute on Aging (NIA)US National Institutes of Health
- Study start
- Sep 2003
- Primary completion
- Jul 2008 (estimated)
- Study completion
- Jul 2008 (estimated)
- First posted
- 14 Oct 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this 12-month study is to determine whether nicotine, administered in the form of nicotine patches, can improve symptoms of memory loss in some people experiencing mild memory problems (referred to in this study as "mild cognitive impairment" or MCI).
Detailed description
The purpose of this study is to determine whether nicotine can improve symptoms of memory loss in some people experiencing mild memory problems (referred to in this study as "mild cognitive impairment" or MCI). The study will last approximately 12 months and will be conducted at 3 clinical sites in the United States.
Recent studies have suggested that one of the causes of memory disorders may be a reduction in a particular chemical substance in the brain. This chemical substance, acetylcholine, is thought to act on certain brain cells in a specific way that helps us to remember and use memories as well as affect our mood. In MCI (and Alzheimer's disease), the level of acetylcholine may be changed, and this may impair brain functioning. Preliminary studies have suggested that short-term administration of nicotine appears to improve memory in patients with mild memory loss and early Alzheimer's disease. Nicotine imitates many of the actions of acetylcholine. By administering nicotine over a longer period of time to patients with MCI, this study could lead to a better understanding of whether nicotine can act to improve memory loss symptoms over the longer term and whether it can help delay the progression of memory loss symptoms. The amount of nicotine in each patch used in this study is the same level found in patches that are used in people who are trying to quit smoking.
This study will include up to twelve visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo Group | Placebo comparator | Drug: Placebo transdermal patchPlacebo for first six months of study; moved to open-label active nicotine for second six months |
| Active Nicotine Group | Experimental | Drug: Transdermal nicotine patchBlinded active nicotine for first six months of study; open-label active nicotine for second six months |
Who may qualify
- Ages
- 55 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- Any significant neurologic disease such as Alzheimer's disease, Parkinson's disease, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic deficits or known structural brain abnormalities.
- Major depression or another major psychiatric disorder as described in DSM-IV within the past 2 years.
- History of alcohol or substance abuse or dependence within the past 2 years (DSM IV criteria).
- Any significant, unstable medical condition.
- Use of any investigational drugs within 30 days or 5 half-lives, whichever is longer, prior to screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transdermal nicotine patchAlso: Nicotroldouble-blind phase: 5mg for 1 week, 10mg for 2 weeks, 15mg for 23 weeks open label phase: 5mg for 1 week, 10mg. for 2 weeks, 15mg. for 23 weeks taper down: 10mg. for 2 weeks, 5mg. for 1 week | Drug | Active Nicotine Group |
| Placebo transdermal patchplacebo patch, 5mg for 1 week, 10mg for 2 weeks, 15mg for 23 weeks | Drug | Placebo Group |
Primary outcome
Safety of transdermal nicotine patch
Time frame: 13 months
2 secondary outcomes
Change in cognitive performance
Time frame: 13 months
Change in global functioning
Time frame: 13 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2008.
- Background: PubMed 15018837Newhouse PA, Potter A, Singh A. Effects of nicotinic stimulation on cognitive performance. Curr Opin Pharmacol. 2004 Feb;4(1):36-46. doi: 10.1016/j.coph.2003.11.001.
- Background: PubMed 14754447Newhouse P, Singh A, Potter A. Nicotine and nicotinic receptor involvement in neuropsychiatric disorders. Curr Top Med Chem. 2004;4(3):267-82. doi: 10.2174/1568026043451401.
- Background: PubMed 11230878Newhouse PA, Potter A, Kelton M, Corwin J. Nicotinic treatment of Alzheimer's disease. Biol Psychiatry. 2001 Feb 1;49(3):268-78. doi: 10.1016/s0006-3223(00)01069-6. No abstract available.
- Nicotine Treatment of Mild Cognitive Impairment (MCI) study at University of VermontLink provided by the sponsor.
Related trials for Age-Related Memory Disorders
Recruiting
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Recruiting
Sleep Related Memory Consolidation in Children With Age Related Focal Epilepsy.
Benign Epilepsy With Centro Temporal Spikes (BECTS), Atypical Benign Partial Epilepsy (ABPE)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Newhouse, MD principal investigator
University of Vermont
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Transdermal nicotine patch in people with Age-Related Memory Disorders, run by National Institute on Aging (NIA) at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of transdermal nicotine patch (time frame: 13 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00091468, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2008.