Alzheimer's DiseaseScopeNCT01841905
Detection of Disease-Related Changes in Pre-Symptomatic Alzheimer's Disease
An observational study of Alzheimer's Disease, run by Rhode Island Hospital at 1 site in United States.
Trial summary
The investigators are conducting a study to try to improve our ability to identify older adults who are at high-risk for progression to Alzheimer's disease, several years before they have symptoms that might reduce their quality of life. Read more about this study
- Who is it for?
- Ages 55 to 80 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Observational Study
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Dec 2016
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals between the ages of 55 and 80 years old, and who have two risk factors for AD (subjective memory complaints as ascertained on a standardized questionnaire and a positive family history for the disease).
Who may be able to join
- Individuals between the ages of 55 and 80 years old (inclusive).
- MMSE total score > 27
- Two risk factors for AD:
- Subjective memory complaints.
- A positive (suspected) first-degree family history for the disease.
- Permitted medications stable for at least 1 month prior to screening.
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- Subjects may take stable doses of antidepressants lacking significant anticholinergic side effects (do not have a history of major depression within the past year).
- Estrogen replacement therapy.
- Adequate visual and auditory acuity to allow neuropsychological testing.
- Good general health or without any clinically significant abnormalities .
- Vitamin supplements (including Vitamin E) will be acceptable.
- Subjects must be willing and able to provide written informed consent.
Who cannot join
- History of major traumatic brain injury, other known neurologic disease or insult
- Mini Mental State Examination (MMSE)total score < 27
- Regular (daily) use of narcotics or antipsychotic medications
- Poorly-controlled major depression or another Axis I psychiatric disorder as described in DSM-IV within the past year.
- Psychotic features, agitation or behavioral problems, within the last 3 months.
- History of alcohol or substance abuse or dependence within the past 2 years (DSM IV criteria).
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- History of schizophrenia (DSM IV criteria).
- Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the protocol including:
- History of systemic cancer within the past 5 years (non-metastatic skin cancers are acceptable).
- History of myocardial infarction in the past year or unstable or severe cardiovascular disease including angina or Congestive Heart Failure (CHF) with symptoms at rest.
- Clinically significant obstructive pulmonary disease or asthma.
- Clinically significant and unstable gastrointestinal disorder within two years.
- Insulin-requiring diabetes or uncontrolled diabetes mellitus.
- Uncontrolled hypertension (systolic BP > 170 or diastolic BP > 100).
- History of clinically significant liver disease, coagulopathy, or vitamin K deficiency within the past 2 years.
- History of symptoms of narrow-angle glaucoma.
- Clinically significant obstructive uropathy
- Use of centrally active beta-blockers, narcotics, methyldopa and clonidine within 4 weeks prior to screening.
- Use of anti-Parkinsonian medications (e.g., Sinemet, amantadine, bromocriptine, pergolide and selegiline) within 2 months prior to screening.
- Use of neuroleptics or narcotic analgesics within 4 weeks prior to screening.
- Use of long-acting benzodiazepines or barbiturates within 4 weeks prior to screen.
- Use of short-acting anxiolytics or sedative-hypnotics more frequently than 2 times per week within 4 weeks prior to screening (note: sedative agents should not be used within 72 hours of the baseline and follow-up visits.
- Initiation or change in dose of an antidepressant lacking significant cholinergic side effects within the 4 weeks prior to screening (use of stable doses of antidepressants for at least 4 weeks prior to screening is acceptable)
- Use of systemic corticosteroids within 3 months prior to screening.
- Medications with significant cholinergic or anticholinergic side effects within 4 weeks prior to screening.
- Use of anti-convulsants within 2 months prior to screening.
- Use of warfarin (Coumadin) within 4 weeks prior to screening.
- Any prior use of any FDA approved medications for the treatment of Alzheimer's disease (e.g., tacrine, donepezil, or other newly approved medications).
- Use of any investigational drugs within 30 days or 5 half-lives, whichever is longer, prior to screening.
- Subjects who, in the investigator's opinion, will not comply with study procedures.
- Known hypersensitivity to F-18, tropicamide, and/or scopolamine or agents of this class of drugs.
Trial locations and contacts
1 site in 1 country.
About this study
The investigators are conducting a study to try to improve our ability to identify older adults who are at high-risk for progression to Alzheimer's disease, several years before they have symptoms that might reduce their quality of life. The investigators believe they can increase the sensitivity of tests of memory and problem solving, by using a very small dose of a medication (scopolamine) that reduces the activity of the principal chemical system in the brain that is changing in the earliest stages of Alzheimer's disease. By pairing this "micro-dose" drug challenge (that is administered with a tiny needle placed just under the surface of the skin on the forearm), with our tests of memory and thinking, it is believed that the investigators can create a "stress test" that is very similar in concept to the use of the exercise treadmill to make the results of a heart EKG more sensitive to detect early disease, as a cardiac stress test for heart disease. The investigators want to create a similar stress test for Alzheimer's disease (AD).
Read the detailed description
We will take pictures of subjects' brains using PET imaging, in healthy older adults (ages 55 to 80 years) who have both a family history of AD, and who have concerns about changes in their memory (but no clinical symptoms of AD), to see how much of a protein - that is related to AD -is in their brains. When all subjects come to the hospital for PET imaging, we will review the entire study plan with them, the risks and benefits of participation, and we will obtain written informed consent at that time. Our goal is to compare performance on our new stress test to these PET imaging results. Once the PET imaging is done, we will have each subject come to our clinical research unit for a day-long baseline visit. In the morning we will give the tests of memory and thinking, and then we will administer the injection of scopolamine at a very low dose. We will then continue to examine the subjects, and to give the memory and thinking tests at 1, 3, 5, 7, and 8 hours post-dosing. Once they have fully-recovered from all effects of the medication, they will be allowed to go home that day. We will then see all subjects again, for much shorter visits to complete the cognitive tests, at both 9 and 18 months after their initial study visit. We will follow all subjects for 18 months to see which of them show very mild but measurable changes on the memory and thinking tests, as we predict that these will be the same persons who also had stronger results on our stress test at the first study visit.
At all three study visits to our clinical research unit, we will obtain measurements using an imaging device that uses infrared and blue light to take picture of the eye and retina. Our secondary goal in this study to search for evidence of the same protein, in the retina, that builds up and is seen with PET imaging of the brain in persons who are at high risk for AD. Finally, we are also collecting a small sample of saliva, at the first visit to our unit, in order to see which subjects have a genetic risk for the disease, as this genetic risk may affect how we interpret the results of our new "cognitive stress test".
In this study, a small dose of an already approved medication (used to treat seasickness) will be used to temporarily, and safely, mimic signs of very early disease during just the first day of testing. This is a methodological study to determine if tests that measure how you think can predict the risk of dementia as we age.
- Conditions
- Alzheimer's Disease
- Being tested
- Observational Study
- Keywords
- Alzheimer's Disease, Family History, Memory Concerns
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational StudyOther
Observational Study
| Study group | Role | What they receive |
|---|---|---|
| Observational Study | Pre-Symptomatic Alzheimers' Disease Receives: Other: Observational Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Groton Maze Learning Test
Total number of correct moves over 5 trials on the Groton Maze Learning Test at 3 hours
Measured: 18 Months
Secondary outcomes (12)
Groton Maze Learning Test
Mean number of correct moves per second on the Groton Maze Learning Test at 3 hours
Measured: 18 Months
CogState One-Back Learning (OBK) Task
Overall performance across study visits.
Measured: 18 Months
12-Item International Shopping List Test - Immediate and Delayed Recall (CogState)
Overall performance across study visits.
Measured: 18 Months
Rentz Face-Name Association Test
Overall performance across study visits.
Measured: 18 Months
Stark Pattern Separation Test
Overall performance across study visits.
Measured: 18 Months
Minnesota Cognitive Acuity Scale (MCAS)
Screening acuity.
Measured: Pre-baseline
Saliva Sample for DNA Analyses (ApoE and BDNF genotyping)
Mutation status.
Measured: Baseline
Non-invasive imaging of macula, retinal function and visual fields
Change over time.
Measured: 18 Months
CogState Once-Card learning (OCL) Task
Overall performance across study visits.
Measured: 18 Months
Amyloid and Alzheimer's Psycho-educational Session
An informational exercise to provide further information about amyloid PET imaging and to determine the impact of this disclosure of study participants.
Measured: 9 and 18 month study visits
Tokyo Subway Navigation
A functional activity of daily living where study participants are given pre-determined destinations / conditions and asked to map the route. Main outcome measure for this assessment is time taken to solve the problem.
Measured: 9 month follow-up visit
MAC-Q
A six-item scale measuring age-related memory decline. An overall index of cognitive decline is calculated by summing scores for all six items with double weighting for item #6. Higher scores indicate greater decline in memory.
Measured: Pre-screen, Baseline, 9 & 18 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2013 (estimated)
- Study startJul 2013
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer, Heidelberg Engineering, Inc., Neurotrack, Optovue, Avid Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Peter J. Snyder, Ph.D., Principal investigator, Sr. Vice President & Chief Research Officer, Lifespan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01841905
- Sponsor's protocol ID
- 900,421-477
- Acronym
- Scope
- Status last verified
- Jan 2016
- First submitted
- 24 Apr 2013
- Last updated
- 20 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Disease-Related Changes in Pre-Symptomatic Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT01841905
- Acronym / sponsor ID
- Scope / 900,421-477
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimer's Disease, Family History, Memory Concerns
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Collaborators
- Pfizer, Heidelberg Engineering, Inc., Neurotrack, Optovue, Avid Pharmaceuticals
- Study start
- Jul 2013
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 29 Apr 2013 (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 investigators are conducting a study to try to improve our ability to identify older adults who are at high-risk for progression to Alzheimer's disease, several years before they have symptoms that might reduce their quality of life. The investigators believe they can increase the sensitivity of tests of memory and problem solving, by using a very small dose of a medication (scopolamine) that reduces the activity of the principal chemical system in the brain that is changing in the earliest stages of Alzheimer's disease. By pairing this "micro-dose" drug challenge (that is administered with a tiny needle placed just under the surface of the skin on the forearm), with our tests of memory and thinking, it is believed that the investigators can create a "stress test" that is very similar in concept to the use of the exercise treadmill to make the results of a heart EKG more sensitive to detect early disease, as a cardiac stress test for heart disease. The investigators want to create a similar stress test for Alzheimer's disease (AD).
Detailed description
We will take pictures of subjects' brains using PET imaging, in healthy older adults (ages 55 to 80 years) who have both a family history of AD, and who have concerns about changes in their memory (but no clinical symptoms of AD), to see how much of a protein - that is related to AD -is in their brains. When all subjects come to the hospital for PET imaging, we will review the entire study plan with them, the risks and benefits of participation, and we will obtain written informed consent at that time. Our goal is to compare performance on our new stress test to these PET imaging results. Once the PET imaging is done, we will have each subject come to our clinical research unit for a day-long baseline visit. In the morning we will give the tests of memory and thinking, and then we will administer the injection of scopolamine at a very low dose. We will then continue to examine the subjects, and to give the memory and thinking tests at 1, 3, 5, 7, and 8 hours post-dosing. Once they have fully-recovered from all effects of the medication, they will be allowed to go home that day. We will then see all subjects again, for much shorter visits to complete the cognitive tests, at both 9 and 18 months after their initial study visit. We will follow all subjects for 18 months to see which of them show very mild but measurable changes on the memory and thinking tests, as we predict that these will be the same persons who also had stronger results on our stress test at the first study visit.
At all three study visits to our clinical research unit, we will obtain measurements using an imaging device that uses infrared and blue light to take picture of the eye and retina. Our secondary goal in this study to search for evidence of the same protein, in the retina, that builds up and is seen with PET imaging of the brain in persons who are at high risk for AD. Finally, we are also collecting a small sample of saliva, at the first visit to our unit, in order to see which subjects have a genetic risk for the disease, as this genetic risk may affect how we interpret the results of our new "cognitive stress test".
In this study, a small dose of an already approved medication (used to treat seasickness) will be used to temporarily, and safely, mimic signs of very early disease during just the first day of testing. This is a methodological study to determine if tests that measure how you think can predict the risk of dementia as we age.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational Study | – | Other: Observational StudyPre-Symptomatic Alzheimers' Disease |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals between the ages of 55 and 80 years old, and who have two risk factors for AD (subjective memory complaints as ascertained on a standardized questionnaire and a positive family history for the disease).
Key inclusion criteria (12 listed)
- Individuals between the ages of 55 and 80 years old (inclusive).
- MMSE total score > 27
- Two risk factors for AD:
- Subjective memory complaints.
- A positive (suspected) first-degree family history for the disease.
Key exclusion criteria (31 listed)
- History of major traumatic brain injury, other known neurologic disease or insult
- Mini Mental State Examination (MMSE)total score < 27
- Regular (daily) use of narcotics or antipsychotic medications
- Poorly-controlled major depression or another Axis I psychiatric disorder as described in DSM-IV within the past year.
- Psychotic features, agitation or behavioral problems, within the last 3 months.
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 |
|---|---|---|
| Observational StudyObservational Study | Other | Observational Study |
Primary outcome
Groton Maze Learning Test
Time frame: 18 Months
Total number of correct moves over 5 trials on the Groton Maze Learning Test at 3 hours
12 secondary outcomes
Groton Maze Learning Test
Time frame: 18 Months
CogState One-Back Learning (OBK) Task
Time frame: 18 Months
12-Item International Shopping List Test - Immediate and Delayed Recall (CogState)
Time frame: 18 Months
Rentz Face-Name Association Test
Time frame: 18 Months
Stark Pattern Separation Test
Time frame: 18 Months
Minnesota Cognitive Acuity Scale (MCAS)
Time frame: Pre-baseline
Saliva Sample for DNA Analyses (ApoE and BDNF genotyping)
Time frame: Baseline
Non-invasive imaging of macula, retinal function and visual fields
Time frame: 18 Months
CogState Once-Card learning (OCL) Task
Time frame: 18 Months
Amyloid and Alzheimer's Psycho-educational Session
Time frame: 9 and 18 month study visits
Tokyo Subway Navigation
Time frame: 9 month follow-up visit
MAC-Q
Time frame: Pre-screen, Baseline, 9 & 18 month follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2016.
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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.
Peter J. Snyder, Ph.D. principal investigator
Sr. Vice President & Chief Research Officer, Lifespan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer's Disease, run by Rhode Island Hospital at 1 site 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 12 inclusion and 31 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 20 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Groton Maze Learning Test (time frame: 18 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jan 2016; AzTrials last refreshed its copy on 7 Nov 2026.