Biomarker Predictors of Memantine Sensitivity in Patients With Alzheimer's Disease

Alzheimer Disease Clinical Trial

Official title:

Biomarker Predictors of Memantine Sensitivity in Patients With Alzheimer's Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03703856
• Other study ID #: R01AG059640-01
• Status: Recruiting
• Phase: Phase 4
• Start date: January 31, 2019
• Est. completion date: June 30, 2024

Study information

• Verified date: December 2023
• Source: University of California, San Diego
• Contact: Joyce Sprock
• Phone: (619) 471-9455
• Email: jsprock[@]ucsd.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The effects of the medication, memantine, on brain functions and the symptoms of Alzheimer's Disease will be tested

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 83 Years

Eligibility

Inclusion:

1. Alzheimer's Disease Research Center-confirmed diagnosis of AD

2. Mini-Mental State Examination (MMSE) score 10-22 OR a Montreal Cognitive Assessment (MOCA) score of 15-24

3. Age 50-83 y

4. Knowledgeable caregiver

5. Ambulatory

6. Medically stable;

7. Audiometric testing (detection < 40 db(A) at 1000 Hz)

8. Informed consent

Exclusion:

1. Active systemic illness (e.g. heart disease, liver failure, renal insufficiency, cancer, HIV, tuberculosis, Hepatitis C)

2. Current psychiatric or neurologic illness other than AD

3. History of vascular disease, myocardial infarction, cerebrovascular accidents, transient ischemic attack, seizure, head injury with loss of consciousness; substance dependence (including alcohol and Opioid)

4. Past treatment with memantine; unable to tolerate acetylcholinesterase inhibitor

5. Investigational drug treatment < 30 d of screening

6. Current meds: amantadine, riluzole, other pro-cognitive medication, opioids

7. Positive urine toxicology for non-prescribed psychoactive substance

8. Actively enrolled in cognitive remediation therapy

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Drug:
• Memantine
Phase 1 will test the acute effects of memantine (20 mg po) vs. placebo (PBO) on early auditory information processing measures in 32 carefully characterized patients with mild-to-moderate severity AD who are not currently taking AD medications. From this "challenge" test, a set of "early auditory information processing memantine sensitivity" measures will be derived for each patient. In Phase 2, all patients will begin an open-label trial of memantine monotherapy, titrated to 10 mg bid, with outcome measures collected after 8, 16 and 24 weeks of treatment. Medication adjustments are not restricted, and response heterogeneity is anticipated.
• Placebo
Phase 1 will test the acute effects of memantine (20 mg po) vs. placebo (PBO) on early auditory information processing measures in 32 carefully characterized patients with mild-to-moderate severity AD who are not currently taking AD medications. From this "challenge" test, a set of "Early auditory information processing P memantine sensitivity" measures will be derived for each patient. In Phase 2, all patients will begin an open-label trial of memantine monotherapy, titrated to 10 mg bid, with outcome measures collected after 8, 16 and 24 weeks of treatment. Medication adjustments are not restricted, and response heterogeneity is anticipated.

Locations

Country	Name	City	State
United States	Clinical Teaching Facility (CTF-B102) at UCSD Medical Center	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline measure in Geriatric Depression Scale (GDS) at 8, 16 and 24 weeks	measures behavioral symptoms	0, 8, 16, 24 weeks
Primary	Change from baseline measure in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog) at 8, 16 and 24 weeks	measures cognitive ability	0, 8, 16, 24 weeks
Secondary	Change from baseline measure in Neuropsychiatric Inventory-Questionnaire (NPI-Q) at 8, 16 and 24 weeks	measures behavioral symptoms	0, 8, 16, 24 weeks