← Trials/Trial dossier/NCT00235716

TEAM-AD

CompletedPhase 3Results posted

A Randomized, Clinical Trial of Vitamin E and Memantine in Alzheimer's Disease

CSP #546 - A Randomized, Clinical Trial of Vitamin E and Memantine in Alzheimer's Disease (TEAM-AD)

Lead sponsor

US Department of Veterans Affairs

Asset

Memantine

Listed sites

Recruiting sites

Enrollment

613

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 12-26

Primary endpoints

•Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS/ADL)•Mini-Mental State Examination (MMSE)•ADAS-Cog

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study ID546

NCT IDNCT00235716

Timeline

Milestones

Study first posted2005-10-10estimated

Study start2007-08 (month precision)

Primary completion2012-09actual (month precision)

Study completion2012-10actual (month precision)

Results first posted2014-01-29estimated

Last update posted2014-07-23estimated

Assets

Drug assets

Memantine

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age40 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

1. Diagnoses of possible or probable Alzheimer's disease (NINCDS-ADRDA)

2. Presence of a caregiver (friend or relative) who can assume responsibility for medication compliance, can accompany the patient to all visits, and rate patient's condition

3. Written informed consent from both the patient (or surrogate) and caregiver

4. An MMSE score between 12 and 26 inclusive

5. Administration of a maintenance dosage of donepezil (5-10mg/d), rivastigmine (6-12mg/d) or rivastigmine (Exelon) patch (4.6 mg or 9.5 mg), galantamine or galantamine ER (16-24mg/d) for a minimum of 4 weeks prior to randomization

6. Agreement not to take vitamin E supplements and/or memantine outside of the study (daily multivitamin is permitted containing up to 100 IU alpha-tocopherol)

Exclusion criteria

1. A non-Alzheimer primary dementia (e.g., vascular dementia, Lewy body dementia, fronto-temporal dementia, vitamin B-12 deficiency, hypothyroidism)

2. Current major depression, delirium, alcohol or psychoactive substance abuse or dependency, schizophrenia, or delusional disorder as defined by DSM-IV

3. Presence of any uncontrolled systemic illness that would interfere with participation in the study or a life expectancy of less than one year

4. Pregnant or intention to become pregnant

5. Enrollment in another interventional clinical trial

6. Current prescription with more than one AChE inhibitor

7. Current prescription for warfarin

8. Use of vitamin E supplements in the past 2 weeks

9. Use of memantine in the past 4 weeks or known intolerance

10. Estimated creatinine clearance less than 5ml/min (Cockcroft-Gault formula)

11. Use of amantadine in the past 2 weeks

Endpoints (14)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Global cognition

Function / daily living

Behavior / neuropsychiatric

Caregiver / quality of life

Other clinical outcomes

Global cognition

4 endpoints

Primary/protocol endpoint

Mini-Mental State Examination Change From Baseline

Time frame:6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Primary/protocol endpoint

Alzheimer's Disease Assessment Scale - Cognitive (ADAS-cog) Change From Baseline

Time frame:6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline

ADAS-Cog

change from baseline, improvement

Primary/registry result

Mini-Mental State Examination Change From Baseline

Time frame:6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), units on a scale	Standard error
Vitamin E6 months minus baselinen=136 Participants	-0.35	0.29
12 months minus baselinen=136 Participants	-0.95	0.34
18 months minus baselinen=136 Participants	-2.00	0.44
24 months minus baselinen=136 Participants	-2.62	0.52
30 months minus baselinen=136 Participants	-3.67	0.61
36 months minus baselinen=136 Participants	-4.97	0.74
42 months minus baselinen=136 Participants	-4.84	0.79
48 months minus baselinen=136 Participants	-5.26	0.94
Average change from baselinen=136 Participants	-2.97	0.33
Memantine6 months minus baselinen=140 Participants	-0.24	0.28
12 months minus baselinen=140 Participants	-1.09	0.34
18 months minus baselinen=140 Participants	-2.62	0.45
24 months minus baselinen=140 Participants	-3.44	0.54
30 months minus baselinen=140 Participants	-3.79	0.63
36 months minus baselinen=140 Participants	-4.26	0.78
42 months minus baselinen=140 Participants	-4.59	0.80
48 months minus baselinen=140 Participants	-5.98	0.98
Average change from baselinen=140 Participants	-3.05	0.33
Vitamin E + Memantine6 months minus baselinen=136 Participants	-0.20	0.29
12 months minus baselinen=136 Participants	-0.65	0.34
18 months minus baselinen=136 Participants	-1.22	0.44
24 months minus baselinen=136 Participants	-2.29	0.53
30 months minus baselinen=136 Participants	-3.16	0.61
36 months minus baselinen=136 Participants	-3.69	0.73
42 months minus baselinen=136 Participants	-3.80	0.74
48 months minus baselinen=136 Participants	-5.70	0.91
Average change from baselinen=136 Participants	-2.80	0.33
Placebo6 months minus baselinen=137 Participants	-0.34	0.29
12 months minus baselinen=137 Participants	-1.39	0.35
18 months minus baselinen=137 Participants	-2.21	0.45
24 months minus baselinen=137 Participants	-2.90	0.55
30 months minus baselinen=137 Participants	-3.26	0.65
36 months minus baselinen=137 Participants	-3.87	0.79
42 months minus baselinen=137 Participants	-4.68	0.83
48 months minus baselinen=137 Participants	-5.42	1.02
Average change from baselinen=137 Participants	-3.16	0.33

Mean Difference (Net)0.1995% CI-0.54 - 0.92p0.84Mixed Models Analysis

Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.

Mean Difference (Net)0.1295% CI-0.61 - 0.84p0.84Mixed Models Analysis

Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.

Mean Difference (Net)0.3795% CI-0.36 - 1.10p0.84Mixed Models Analysis

Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.

Mean Difference (Net)0.1795% CI-0.56 - 0.90p0.84Mixed Models Analysis

Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.

Mean Difference (Net)0.2595% CI-0.47 - 0.98p0.84Mixed Models Analysis

Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.

Mean Difference (Net)0.0895% CI-0.65 - 0.80p0.84Mixed Models Analysis

Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.

Primary/registry result

Alzheimer's Disease Assessment Scale - Cognitive (ADAS-cog) Change From Baseline

Time frame:6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), units on a scale	Standard error
Vitamin E6 months minus baselinen=135 Participants	1.38	0.63
12 months minus baselinen=135 Participants	2.40	0.72
18 months minus baselinen=135 Participants	4.34	0.91
24 months minus baselinen=135 Participants	4.32	1.10
30 months minus baselinen=135 Participants	7.87	1.31
36 months minus baselinen=135 Participants	9.00	1.53
42 months minus baselinen=135 Participants	10.35	1.60
48 months minus baselinen=135 Participants	10.73	1.87
Average change from baselinen=135 Participants	5.97	0.70
Memantine6 months minus baselinen=140 Participants	1.11	0.62
12 months minus baselinen=140 Participants	3.32	0.72
18 months minus baselinen=140 Participants	5.69	0.91
24 months minus baselinen=140 Participants	6.73	1.12
30 months minus baselinen=140 Participants	7.64	1.34
36 months minus baselinen=140 Participants	8.31	1.60
42 months minus baselinen=140 Participants	8.24	1.64
48 months minus baselinen=140 Participants	11.74	1.97
Average change from baselinen=140 Participants	6.38	0.70
Vitamin E + Memantine6 months minus baselinen=136 Participants	1.53	0.63
12 months minus baselinen=136 Participants	2.48	0.72
18 months minus baselinen=136 Participants	3.46	0.90
24 months minus baselinen=136 Participants	5.76	1.11
30 months minus baselinen=136 Participants	5.85	1.30
36 months minus baselinen=136 Participants	8.26	1.50
42 months minus baselinen=136 Participants	7.97	1.51
48 months minus baselinen=136 Participants	9.70	1.82
Average change from baselinen=136 Participants	6.13	0.71
Placebo6 months minus baselinen=137 Participants	3.04	0.63
12 months minus baselinen=137 Participants	4.26	0.74
18 months minus baselinen=137 Participants	6.04	0.92
24 months minus baselinen=137 Participants	6.71	1.15
30 months minus baselinen=137 Participants	8.90	1.38
36 months minus baselinen=137 Participants	10.77	1.63
42 months minus baselinen=137 Participants	10.61	1.69
48 months minus baselinen=137 Participants	10.85	2.04
Average change from baselinen=137 Participants	7.78	0.70

Mean Difference (Net)-1.8095% CI-3.28 - -0.33p0.10Mixed Models Analysis

Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.

Mean Difference (Net)-1.3995% CI-2.85 - 0.07p0.25Mixed Models Analysis

Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.

Mean Difference (Net)-1.6595% CI-3.12 - -0.17p0.14Mixed Models Analysis

Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.

Mean Difference (Net)0.1595% CI-1.32 - 1.63p0.84Mixed Models Analysis

Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.

Mean Difference (Net)-0.2695% CI-1.72 - 1.21p0.84Mixed Models Analysis

Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.

Mean Difference (Net)-0.4195% CI-1.88 - 1.06p0.84Mixed Models Analysis

Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.

Function / daily living

4 endpoints

Primary/protocol endpoint

Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS/ADL) Inventory Change From Baseline

Time frame:6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline

change from baseline, improvement

Primary/registry result

Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS/ADL) Inventory Change From Baseline

Time frame:6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), units on a scale	Standard error
Vitamin E6 months minus baselinen=140 Participants	-1.72	0.95
12 months minus baselinen=140 Participants	-4.29	1.20
18 months minus baselinen=140 Participants	-8.01	1.40
24 months minus baselinen=140 Participants	-11.88	1.66
30 months minus baselinen=140 Participants	-15.84	1.94
36 months minus baselinen=140 Participants	-19.71	2.34
42 months minus baselinen=140 Participants	-25.30	2.57
48 months minus baselinen=140 Participants	-26.55	3.11
Average change from baselinen=140 Participants	-13.81	1.11
Memantine6 months minus baselinen=142 Participants	-2.40	0.94
12 months minus baselinen=142 Participants	-6.99	1.21
18 months minus baselinen=142 Participants	-9.32	1.42
24 months minus baselinen=142 Participants	-14.06	1.70
30 months minus baselinen=142 Participants	-18.30	1.97
36 months minus baselinen=142 Participants	-18.78	2.43
42 months minus baselinen=142 Participants	-23.48	2.65
48 months minus baselinen=142 Participants	-24.60	3.18
Average change from baselinen=142 Participants	-14.98	1.10
Vitamin E + Memantine6 months minus baselinen=139 Participants	-2.78	0.96
12 months minus baselinen=139 Participants	-6.60	1.21
18 months minus baselinen=139 Participants	-7.98	1.41
24 months minus baselinen=139 Participants	-12.82	1.68
30 months minus baselinen=139 Participants	-15.66	1.97
36 months minus baselinen=139 Participants	-18.89	2.32
42 months minus baselinen=139 Participants	-23.44	2.52
48 months minus baselinen=139 Participants	-29.25	3.08
Average change from baselinen=139 Participants	-15.20	1.11
Placebo6 months minus baselinen=140 Participants	-4.52	0.95
12 months minus baselinen=140 Participants	-8.11	1.23
18 months minus baselinen=140 Participants	-10.21	1.43
24 months minus baselinen=140 Participants	-16.18	1.74
30 months minus baselinen=140 Participants	-19.67	2.06
36 months minus baselinen=140 Participants	-24.82	2.51
42 months minus baselinen=140 Participants	-28.13	2.76
48 months minus baselinen=140 Participants	-27.55	3.38
Average change from baselinen=140 Participants	-16.96	1.11

Mean Difference (Net)3.1595% CI0.92 - 5.39p0.03Mixed Models Analysis

Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.

Mean Difference (Net)1.9895% CI-0.24 - 4.20p0.40Mixed Models Analysis

Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.

Mean Difference (Net)1.7695% CI-0.48 - 4.00p0.49Mixed Models Analysis

Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.

Mean Difference (Net)-1.3995% CI-3.63 - 0.85p0.60Mixed Models Analysis

Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.

Mean Difference (Net)-0.2295% CI-2.44 - 2.01p0.85Mixed Models Analysis

Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.

Mean Difference (Net)1.1895% CI-1.04 - 3.39p0.60Mixed Models Analysis

Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.

Secondary/protocol endpoint

Dependence Scale: Time to Event Analysis (Increase of of One Dependence Level)

Time frame:Every 6 months to a maximum of 4 years

time to event, event

Secondary/registry result

Dependence Scale: Time to Event Analysis (Increase of of One Dependence Level)

Time frame:Every 6 months to a maximum of 4 years

time to event, event

Posted result

Group	Value (number), participants	Reported bounds
Vitamin En=140 Participants	80	-
Memantinen=142 Participants	87	-
Vitamin E + Memantinen=139 Participants	87	-
Placebon=140 Participants	79	-

p0.69Log Rank

Behavior / neuropsychiatric

2 endpoints

Primary/protocol endpoint

Neuropsychiatric Inventory Change From Baseline

Time frame:6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Primary/registry result

Neuropsychiatric Inventory Change From Baseline

Time frame:6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), units on a scale	Standard error
Vitamin E6 months minus baselinen=140 Participants	-1.24	1.07
12 months minus baselinen=140 Participants	-1.04	1.21
18 months minus baselinen=140 Participants	0.93	1.40
24 months minus baselinen=140 Participants	2.16	1.74
30 months minus baselinen=140 Participants	3.21	1.70
36 months minus baselinen=140 Participants	2.15	1.97
42 months minus baselinen=140 Participants	0.81	2.64
48 months minus baselinen=140 Participants	-0.60	2.53
Average change from baselinen=140 Participants	0.79	1.00
Memantine6 months minus baselinen=142 Participants	-0.20	1.06
12 months minus baselinen=142 Participants	0.31	1.22
18 months minus baselinen=142 Participants	1.18	1.43
24 months minus baselinen=142 Participants	4.29	1.79
30 months minus baselinen=142 Participants	2.62	1.71
36 months minus baselinen=142 Participants	3.24	2.07
42 months minus baselinen=142 Participants	3.63	2.75
48 months minus baselinen=142 Participants	2.79	2.60
Average change from baselinen=142 Participants	1.87	1.00
Vitamin E + Memantine6 months minus baselinen=139 Participants	-0.47	1.08
12 months minus baselinen=139 Participants	-0.17	1.22
18 months minus baselinen=139 Participants	0.41	1.41
24 months minus baselinen=139 Participants	1.98	1.77
30 months minus baselinen=139 Participants	2.16	1.71
36 months minus baselinen=139 Participants	2.79	1.95
42 months minus baselinen=139 Participants	1.85	2.54
48 months minus baselinen=139 Participants	5.14	2.54
Average change from baselinen=139 Participants	1.79	1.00
Placebo6 months minus baselinen=140 Participants	0.46	1.07
12 months minus baselinen=140 Participants	1.08	1.24
18 months minus baselinen=140 Participants	4.06	1.44
24 months minus baselinen=140 Participants	3.59	1.84
30 months minus baselinen=140 Participants	1.66	1.81
36 months minus baselinen=140 Participants	0.60	2.16
42 months minus baselinen=140 Participants	3.64	2.89
48 months minus baselinen=140 Participants	0.30	2.79
Average change from baselinen=140 Participants	2.26	1.01

Mean Difference (Net)-1.4695% CI-3.55 - 0.63p0.94Mixed Models Analysis

Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.

Mean Difference (Net)-0.3995% CI-2.47 - 1.70p0.94Mixed Models Analysis

Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.

Mean Difference (Net)-0.4795% CI-2.57 - 1.63p0.94Mixed Models Analysis

Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.

Mean Difference (Net)0.9995% CI-1.09 - 3.07p0.94Mixed Models Analysis

Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.

Mean Difference (Net)-0.0895% CI-2.16 - 1.99p0.94Mixed Models Analysis

Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.

Mean Difference (Net)-1.0895% CI-3.14 - 0.99p0.94Mixed Models Analysis

Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.

Caregiver / quality of life

2 endpoints

Primary/protocol endpoint

Caregiver Activity Survey Change From Baseline

Time frame:6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline

change from baseline, improvement

Primary/registry result

Caregiver Activity Survey Change From Baseline

Time frame:6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), hours per day	Standard error
Vitamin E6 months minus baselinen=140 Participants	-0.93	0.82
12 months minus baselinen=140 Participants	-0.18	1.00
18 months minus baselinen=140 Participants	2.12	1.20
24 months minus baselinen=140 Participants	1.60	1.09
30 months minus baselinen=140 Participants	4.14	1.22
36 months minus baselinen=140 Participants	7.69	2.30
42 months minus baselinen=140 Participants	4.95	1.81
48 months minus baselinen=140 Participants	10.17	2.74
Average change from baselinen=140 Participants	3.35	0.78
Memantine6 months minus baselinen=142 Participants	0.99	0.81
12 months minus baselinen=142 Participants	2.72	1.01
18 months minus baselinen=142 Participants	3.77	1.22
24 months minus baselinen=142 Participants	3.06	1.13
30 months minus baselinen=142 Participants	5.22	1.25
36 months minus baselinen=142 Participants	5.72	2.43
42 months minus baselinen=142 Participants	9.46	1.89
48 months minus baselinen=142 Participants	9.27	2.80
Average change from baselinen=142 Participants	5.52	0.78
Vitamin E + Memantine6 months minus baselinen=139 Participants	1.08	0.83
12 months minus baselinen=139 Participants	1.39	1.01
18 months minus baselinen=139 Participants	2.69	1.20
24 months minus baselinen=139 Participants	2.82	1.11
30 months minus baselinen=139 Participants	3.41	1.24
36 months minus baselinen=139 Participants	4.90	2.24
42 months minus baselinen=139 Participants	5.48	1.73
48 months minus baselinen=139 Participants	13.80	2.74
Average change from baselinen=139 Participants	5.00	0.78
Placebo6 months minus baselinen=140 Participants	1.20	0.82
12 months minus baselinen=140 Participants	1.89	1.04
18 months minus baselinen=140 Participants	3.16	1.23
24 months minus baselinen=140 Participants	3.45	1.16
30 months minus baselinen=140 Participants	4.36	1.32
36 months minus baselinen=140 Participants	10.68	2.51
42 months minus baselinen=140 Participants	10.62	1.99
48 months minus baselinen=140 Participants	12.17	3.03
Average change from baselinen=140 Participants	5.14	0.79

Mean Difference (Net)-1.7995% CI-3.35 - -0.23p0.12Mixed Models Analysis

Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.

Mean Difference (Net)0.3895% CI-1.18 - 1.94p0.86Mixed Models Analysis

Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.

Mean Difference (Net)-0.1495% CI-1.70 - 1.42p0.86Mixed Models Analysis

Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.

Mean Difference (Net)1.6595% CI0.11 - 3.19p0.14Mixed Models Analysis

Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.

Mean Difference (Net)-0.5295% CI-2.07 - 1.02p0.86Mixed Models Analysis

Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.

Mean Difference (Net)-2.1795% CI-3.71 - -0.63p0.03Mixed Models Analysis

Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.

Other clinical outcomes

2 endpoints

Other/protocol endpoint

All-cause Mortality

Time frame:up to 4 years

descriptive

Other_pre_specified/registry result

All-cause Mortality

Time frame:up to 4 years

descriptive

Posted result

Group	Value (number), participants	Reported bounds
Vitamin En=152 Participants	26	-
Memantinen=155 Participants	39	-
Vitamin E + Memantinen=154 Participants	32	-
Placebon=152 Participants	31	-

Hazard Ratio (HR)0.8795% CI0.67 - 1.13p0.31Log Rank

Hazard Ratio (HR)1.0695% CI0.91 - 1.24p0.47Log Rank

Hazard Ratio (HR)0.9495% CI0.57 - 1.54p0.80Log Rank

Publications (2)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.