Trial Outcomes & Findings for Corticolimbic Degeneration and Treatment of Dementia (NCT NCT00768261)
NCT ID: NCT00768261
Last Updated: 2018-09-11
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
39 participants
Primary outcome timeframe
2 years
Results posted on
2018-09-11
Participant Flow
39 subjects enrolled in Group3.14 maps have passed inspection for quality and are included in final analysis. Subject data from a previously published study of donepezil(Wang et al.,2010) with 18 very mild dementia of the Alzheimer's type patients treated with donepezil,14 untreated with mild DAT, and 56 cognitively normal individuals are included.
Participant milestones
| Measure |
1 Very Mild to Mild DAT Untreated
Group 1) subjects with very mild (CDR 0.5) to mild (CDR 1) DAT that are untreated with either cholinesterase inhibitors or memantine
|
2 Very Mild to Mild DAT Treated With Donepezil
Group 2) subjects with very mild (CDR 0.5) to mild (CDR 1) DAT that are treated with donepezil.
Donepezil (Aricept®): 5mg/day for six weeks and if no serious side-effects increased to 10mg/dy.
|
3 Very Mild to Mild DAT Treated With the Combination
Group 3) subjects with very mild (CDR 0.5) to mild (CDR 1) DAT that are treated with the combination of donepezil and memantine.
Memantine (Namenda®): 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.
Memantine (Namenda®): Initial dose of 10mg/day and increased to full dose of 20mg/day if no serious side-effects
|
4 Nondemented Comparison Subjects.
Group 4) nondemented comparison subjects.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
14
|
18
|
39
|
56
|
|
Overall Study
COMPLETED
|
14
|
18
|
14
|
56
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
25
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Corticolimbic Degeneration and Treatment of Dementia
Baseline characteristics by cohort
| Measure |
1 Very Mild to Mild DAT Untreated
n=14 Participants
Group 1) subjects with very mild (CDR 0.5) to mild (CDR 1) DAT that are untreated with either cholinesterase inhibitors or memantine
|
2 Very Mild to Mild DAT Treated With Donepezil
n=18 Participants
Group 2) subjects with very mild (CDR 0.5) to mild (CDR 1) DAT that are treated with donepezil.
Donepezil (Aricept®): 5mg/day for six weeks and if no serious side-effects increased to 10mg/dy.
|
3 Very Mild to Mild DAT Treated With the Combination
n=14 Participants
Group 3) subjects with very mild (CDR 0.5) to mild (CDR 1) DAT that are treated with the combination of donepezil and memantine.
Memantine (Namenda®): 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.
Memantine (Namenda®): Initial dose of 10mg/day and increased to full dose of 20mg/day if no serious side-effects
|
4 Nondemented Comparison Subjects.
n=56 Participants
Group 4) nondemented comparison subjects.
|
Total
n=102 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
13 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
56 Participants
n=4 Participants
|
100 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
55 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
47 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
14 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
56 Participants
n=4 Participants
|
102 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 2 yearsOutcome measures
| Measure |
1 Very Mild to Mild DAT Untreated
n=14 Participants
Group 1) subjects with very mild (CDR 0.5) to mild (CDR 1) DAT that are untreated with either cholinesterase inhibitors or memantine
|
2 Very Mild to Mild DAT Treated With Donepezil
n=18 Participants
Group 2) subjects with very mild (CDR 0.5) to mild (CDR 1) DAT that are treated with donepezil.
Donepezil (Aricept®): 5mg/day for six weeks and if no serious side-effects increased to 10mg/dy.
|
3 Very Mild to Mild DAT Treated With the Combination
n=14 Participants
Group 3) subjects with very mild (CDR 0.5) to mild (CDR 1) DAT that are treated with the combination of donepezil and memantine.
Memantine (Namenda®): 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.
Memantine (Namenda®): Initial dose of 10mg/day and increased to full dose of 20mg/day if no serious side-effects
|
4 Nondemented Comparison Subjects.
n=56 Participants
Group 4) nondemented comparison subjects.
|
|---|---|---|---|---|
|
Rate of Change of Hippocampal Volume Slope
left hippocampal volume slope
|
-70.2418748 mm^3/year
Standard Deviation 31.4801034
|
-88.4738591 mm^3/year
Standard Deviation 52.2621175
|
-94.0768115 mm^3/year
Standard Deviation 48.349487
|
-46.9484805 mm^3/year
Standard Deviation 83.5825530
|
|
Rate of Change of Hippocampal Volume Slope
right hippocampal volume slope
|
-99.9437062 mm^3/year
Standard Deviation 65.1619838
|
-94.3258652 mm^3/year
Standard Deviation 44.7959659
|
-125.0687876 mm^3/year
Standard Deviation 72.5509442
|
-80.0840066 mm^3/year
Standard Deviation 130.3453711
|
SECONDARY outcome
Timeframe: two yearsPopulation: We combined the DAT patients who received any treatment (donepezil or combined) \& used the annual roc in ADAS-Cog to equally separate them into 3 subgroups; improving (1/3 negative ADAS-Cog roc), stable (1/3 near-zero ADAS-Cog change) \& worsening (1/3 positive ADAS-Cog change).
The ADAS-Cog evaluates cognition and differentiates normal from impaired cognitive functioning. The total score is the summed number of errors in each task. The greater the impairment, the greater the score. We combined the dementia of the Alzheimer's type patients receiving all treatments together and grouped them into 3 subgroups according to the rates of change(roc) of their ADAS-Cog scores. To determine trends in hippocampal volume atrophy over time we compared the patients showing most negative ADAS-Cog rate of change (improving), patients with most positive ADAS-cog roc (worsening), patients with intermediate, near-zero ADAS-Cog roc (stable) .
Outcome measures
| Measure |
1 Very Mild to Mild DAT Untreated
n=10 Participants
Group 1) subjects with very mild (CDR 0.5) to mild (CDR 1) DAT that are untreated with either cholinesterase inhibitors or memantine
|
2 Very Mild to Mild DAT Treated With Donepezil
n=11 Participants
Group 2) subjects with very mild (CDR 0.5) to mild (CDR 1) DAT that are treated with donepezil.
Donepezil (Aricept®): 5mg/day for six weeks and if no serious side-effects increased to 10mg/dy.
|
3 Very Mild to Mild DAT Treated With the Combination
n=11 Participants
Group 3) subjects with very mild (CDR 0.5) to mild (CDR 1) DAT that are treated with the combination of donepezil and memantine.
Memantine (Namenda®): 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.
Memantine (Namenda®): Initial dose of 10mg/day and increased to full dose of 20mg/day if no serious side-effects
|
4 Nondemented Comparison Subjects.
Group 4) nondemented comparison subjects.
|
|---|---|---|---|---|
|
Comparison of Combined DAT Patients' Mean (SD) Hippocampal Volume Slope (mm^3/Year) Rate of Change
left hippocampal volume slope
|
-70 (mm^3/year)
Standard Deviation 56
|
-106 (mm^3/year)
Standard Deviation 55
|
-100 (mm^3/year)
Standard Deviation 37
|
—
|
|
Comparison of Combined DAT Patients' Mean (SD) Hippocampal Volume Slope (mm^3/Year) Rate of Change
right hippocampal volume slope
|
-77 (mm^3/year)
Standard Deviation 51
|
-141 (mm^3/year)
Standard Deviation 78
|
-105 (mm^3/year)
Standard Deviation 34
|
—
|
Adverse Events
1 Very Mild to Mild DAT Untreated
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
2 Very Mild to Mild DAT Treated With Donepezil
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
3 Very Mild to Mild DAT Treated With the Combination
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
4 Nondemented Comparison Subjects.
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place