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Find more clinical trials

Exendin-4 in Alzheimer's Disease

Start: November 2010
End: November 2016
Enrollment: 100

What Is This Study About?

Exendin-4 (exenatide), a medication used to treat Type 2 diabetes, will be tested as a treatment for early-stage Alzheimer's disease or mild cognitive impairment (MCI). It has shown promising results in protecting nerve cells in the brain from the damaging processes associated with Alzheimer's.

 

Do I Qualify To Participate in This Study?

Minimum Age: 60 Years

Maximum Age: N/A

Must have:

  • Clinical Dementia Rating of 0.5 or 1; Memory Box score of at least 0.5; Mini Mental Status Examination score of more than 20
  • Clinical diagnosis of (amnestic or mixed) MCI or early Alzheimer's disease
  • Memory deficit shown by neuropsychological or clinical testing
  • Hamilton Depression Scale score of 12 or less on the 17-item scale
  • Amyloid-beta 42 level of less than 192 in cerebrospinal fluid
  • If taking medications, including cholinesterase inhibitors and/or memantine, on stable dose for at least 4 weeks prior to screening
  • Fluency in English
  • Informant or caregiver who has frequent contact with participant (10 hours per week or more) must be appointed as durable power of attorney for research and medical care at NIA, accompany participant to clinic visits, provide historical information regarding participant's cognitive status, and assist with injections of study drug
  • Good general health

Must NOT have:

  • Other significant neurological disease such as Parkinson's disease, vascular dementia, frontotemporal dementia, Huntington's disease, or multiple sclerosis
  • History of significant head trauma followed by persistent neurological defaults or known structural brain abnormalities
  • Positive RPR or HIV
  • Abnormal laboratory test results
  • Anticoagulant therapy such as Coumadin; aspirin allowed
  • History of significant psychiatric disease with significant impairment in thought processes, including schizophrenia, bipolar disease, psychosis
  • Current alcoholism or substance abuse or significant history of these conditions
  • Diabetes
  • Severe renal impairment or end-stage renal disease
  • Current or previous treatment with exenatide
  • History of pancreatitis, active upper gastrointestinal, hepatic, or gallbladder disease
  • Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
  • History of repeated hypoglycemia
  • Body mass index of less than 18 (study drug causes weight loss)
  • Allergy to Exendin-4 or substances in the injection pen (metacresol, mannitol, glacial acetic acid, sodium acetate trihydrate, water)
  • Participation in other studies of investigational treatments for Alzheimer's disease

If I Qualify, Who Do I Contact?

Contact study personnel listed either under the general study contact or the location nearest you.

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?

Who Sponsors This Study?

Lead: National Institute on Aging (NIA)

Source: ClinicalTrials.gov ID: NCT01255163

alzheimers.gov

An official website of the U.S. government, managed by the National Institute on Aging at the National Institutes of Health