Corticolimbic Degeneration and Treatment of Dementia

NCT00768261 | Completed Phase 4 Results

• 1 other identifier: 5R01MH060883-06
• Study Type: interventional
• Target: 39
• Locations: 0 countries
• Sites: N/A

Brief Summary

The overall purpose of this research is to determine if there is a relationship between your symptoms of Dementia of the Alzheimers type and changes in the size and shape of certain brain structures during combined Donepezil (Aricept®) and Memantine (Namenda®) treatment.

Conditions

Dementia

Keywords

Dementia of the Alzheimer type

Outcome Measures

Primary Outcomes (1)

• Rate of Change of Hippocampal Volume Slope

  2 years

Secondary Outcomes (1)

• Comparison of Combined DAT Patients' Mean (SD) Hippocampal Volume Slope (mm^3/Year) Rate of Change

  two years

Study Arms (4)

Very Mild to Mild DAT Untreated

NO INTERVENTION

Group 1) subjects with very mild (CDR 0.5) to mild (CDR 1) DAT that are untreated with either cholinesterase inhibitors or memantine

Very Mild-Mild DAT Treated W/ Donepezil

ACTIVE COMPARATOR

Group 2) subjects with very mild (CDR 0.5) to mild (CDR 1) DAT that are treated with Donepezil (Aricept®).

Drug: Donepezil (Aricept®)

Very Mild-Mild DAT Treated W/Combination

ACTIVE COMPARATOR

Group 3) subjects with very mild (CDR 0.5) to mild (CDR 1) DAT that are treated with the combination of Donepezil (Aricept®) and Memantine (Namenda®)

Drug: Memantine (Namenda®); Drug: Donepezil (Aricept®)

Nondemented Comparison Subjects

NO INTERVENTION

Group 4) nondemented comparison subjects.

Interventions

Memantine (Namenda®) DRUG

Drug treatment will begin with 5 mg/day of donepezil for six weeks. After six weeks of such treatment, the subjects symptoms will be re-evaluated and any side-effects of treatment assessed and recorded. If no serious side-effects of donepezil are encountered, the dose of donepezil will be increased to 10 mg/day. For subjects prescribed the combination of donepezil and memantine, memantine (20 mg/day) will be added to the drug treatment regimen after the dose of donepezil has been established (i.e., at six weeks). Again, memantine will be initially started at 10 mg/day and increased to its full dose only if no serious side-effects are encountered.

Also known as: Namenda

Very Mild-Mild DAT Treated W/Combination

Donepezil (Aricept®) DRUG

5mg/day for six weeks and if no serious side-effects increased to 10mg/dy.

Also known as: Aricept

Very Mild-Mild DAT Treated W/ Donepezil; Very Mild-Mild DAT Treated W/Combination

Eligibility Criteria

• Age: 50 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Northwestern University: collaborator

MeSH Terms

Conditions

Dementia

Interventions

Memantine; Donepezil

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amantadine; Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Indans; Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Limitations and Caveats

Interpretation of results limited to evaluating overall effects in naturalistic groups undergoing 2 drug treatments;Insufficient subjects to determine possible existence of DAT patient subgroups showing drug-specific slowing of disease progression

Results Point of Contact

• Title: John G. Csernansky, MD
• Organization: Washington University

jgc@northwestern.edu

(312) 926-2323

Study Officials

• John Morris, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2008
• First Posted: October 8, 2008
• Study Start: November 1, 2004
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: September 11, 2018
• Results First Posted: September 11, 2018

Record last verified: 2018-08