Start:
May 2013
End:
December 2016
Enrollment:
60
What Is This Study About?
This observational study seeks to better identify older adults who are at high risk for progression to Alzheimer's disease several years before they develop dementia symptoms. Investigators aim to create a "stress test" for Alzheimer's, similar in concept to a cardiac stress test for heart disease.
Do I Qualify To Participate in This Study?
Must have:
- Mini Mental State Examination score of more than 27
- Subjective memory complaints
- Suspected family history of Alzheimer's disease (affecting parents, children, and/or siblings)
- On stable dose of permitted medications for at least 1 month before screening; permitted are antidepressants lacking significant anticholinergic side effects, estrogen replacement therapy, and vitamin supplements
- Adequate seeing and hearing ability to allow neuropsychological testing
- Good general health without any clinically significant abnormalities
Must NOT have:
- History of major traumatic brain injury or other known neurologic disease or insult
- Mini Mental State Examination score of less than 27
- Poorly controlled major depression or other psychiatric disorder 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
- History of schizophrenia
- Any significant systemic illness or unstable medical condition, including:
- History of systemic cancer within the past 5 years (non-metastatic skin cancers are acceptable)
- History of myocardial infarction within the past year or unstable or severe cardiovascular disease such as angina or congestive heart failure
- Clinically significant obstructive pulmonary disease or asthma
- Clinically significant and unstable gastrointestinal disorder within the past 2 years
- Diabetes requiring insulin or that is uncontrolled
- Uncontrolled hypertension (systolic blood pressure > 170 mmHg or diastolic BP > 100 mmHg)
- 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
- Prohibited medications:
- Daily use of narcotics or antipsychotic medications
- Within 4 weeks prior to screening: centrally active beta-blockers, narcotics, methyldopa, or clonidine; neuroleptics or narcotic analgesics; long-acting benzodiazepines or barbiturates; short-acting anxiolytics or sedative-hypnotics more than twice a week; initiation or change in dose of an antidepressant lacking significant cholinergic side effects (use of stable doses of antidepressants is acceptable); medications with significant cholinergic or anticholinergic side effects; warfarin (Coumadin)
- Within 2 months prior to screening: anti-parkinsonian medications (e.g., Sinemet, amantadine, bromocriptine, pergolide, or selegiline); anticonvulsants
- Within 3 months prior to screening: systemic corticosteroids
- Prior use of any FDA-approved medication for Alzheimer's disease
- Any investigational drug within 30 days or 5 half-lives, whichever is longer, prior to screening
- Known hypersensitivity to F-18, tropicamide, and/or scopolamine or agents of this class of drugs
Need Help?
Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at
800-438-4380
or
email ADEAR.
Where Is This Study Located?
Collaborator Sponsor
Source:
ClinicalTrials.gov ID:
NCT01841905