Detection of Disease-Related Changes in Pre-Symptomatic Alzheimer's Disease

Status unconfirmed

Conditions studied: Alzheimer's Disease

In brief

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).

Key facts

Study ID

NCT01841905

Run by

Rhode Island Hospital

People needed

60

Starts

2013-07-01

Expected to finish

2016-12-01

Last updated by the study team

2016-01-20

Who can join

Age: 55 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• 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.

You may not qualify if…

• 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).
• 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.

Where it is running

• Lifespan — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

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