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CompletedPhase 4Results posted

The Use of Galantamine (Reminyl ER) in Patients With MIXed Dementia: Effects on Cognition and Quality of Life

Lead sponsor

Janssen-Cilag Farmaceutica Ltda.

Assets

Galantamine / Nimodipine

Listed sites

Recruiting sites

Enrollment

actual

Study population

Mixed / unspecified dementia

Key I/E criterion

•MMSE 10-26

Primary endpoints

•Reaction Time for Simple Reaction Time Test•Reaction Time for Two-choice Reaction Time Test•Reaction Time for Face Recognition Test

Identifiers

Registered as

Org study IDCR014938

Secondary IDGALDEM4008Janssen-Cilag Farmaceutica Ltda.

NCT IDNCT00814658

Timeline

Milestones

Study start2008-06 (month precision)

Study first posted2008-12-25estimated

Primary completion2009-10actual (month precision)

Study completion2009-10actual (month precision)

Last update posted2013-08-26estimated

Results first posted2013-08-26estimated

Assets

Drug assets

Galantamine Nimodipine

Study populations

Who this study enrolls

Mixed / unspecified dementia

Eligibility

Who can enroll

Minimum age65 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Patients should fulfill DSM-IV criteria for dementia (APA, 1994)

•Patients should fulfill criteria for AD with cerebrovascular disease according to NINDS-AIREN criteria (Román et al., 1993)

•The severity of dementia should be mild to moderate, as defined by MMSE score between 10 and 26 (inclusive)

•Patients (and their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study

Exclusion criteria

•History of neurodegenerative disorders such as Parkinson's disease, Pick's disease or Huntington's chorea, Down's syndrome, Creutzfeldt-Jacob disease. Patients who have mild extrapyramidal signs, for which no treatment is required, are not excluded from the trial

•History of liver or renal insufficiency

•significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurological, psychiatric, or metabolic disturbances in the past 6 months

•Patients who have previously received M1 agonists or cholinesterase inhibitors (tacrine, donepezil, metrifonate, rivastigmine) for treatment of Alzheimer's disease, no matter if approved or experimental can be included in this trial provided there was at least a washout period of 60 days prior to the screening assessments

•History of drug or alcohol abuse within the last year or prior prolonged history

•History of severe drug allergy or hypersensitivity

•including recorded hypersensitivity to cholinesterase inhibitors, choline agonists or similar agents, or bromide

•Subjects who have previously been enrolled in other galantamine trials.

Endpoints (20)

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

Caregiver / quality of life

Behavior / neuropsychiatric

Other clinical outcomes

Global cognition

10 endpoints

Primary/protocol endpoint

Reaction Time for Simple Reaction Time Test at Baseline, Week 8, and Week 24

Time frame:Baseline, Week 8, Week 24

descriptive

Primary/protocol endpoint

Reaction Time for Two-choice Reaction Time Test at Baseline, Week 8, and Week 24

Time frame:Baseline, Week 8, Week 24

descriptive

Primary/protocol endpoint

Reaction Time for Face Recognition Test at Baseline, Week 8, and Week 24

Time frame:Baseline, Week 8, Week 24

descriptive

Primary/protocol endpoint

Reaction Time for Word Recognition and Learning Test at Baseline, Week 8, and Week 24

Time frame:Baseline, Week 8, Week 24

descriptive

Primary/registry result

Reaction Time for Simple Reaction Time Test at Baseline, Week 8, and Week 24

Time frame:Baseline, Week 8, Week 24

descriptive

Posted result

Group	Value (mean), milliseconds	Standard deviation
Galantamine + Nimodipine (Baseline)n=9 Participants	1024.06	1307.97
Galantamine + Placebo (Baseline)n=12 Participants	729.18	394.88
Galantamine + Nimodipine (Week 8)n=5 Participants	466.60	297.53
Galantamine + Placebo (Week 8)n=9 Participants	671.33	298.38
Galantamine + Nimodipine (Week 24)n=5 Participants	467.60	336.69
Galantamine + Placebo (Week 24)n=8 Participants	584.44	320.37

Primary/registry result

Reaction Time for Two-choice Reaction Time Test at Baseline, Week 8, and Week 24

Time frame:Baseline, Week 8, Week 24

descriptive

Posted result

Group	Value (mean), milliseconds	Standard deviation
Galantamine + Nimodipine (Baseline)n=9 Participants	1919.72	1801.13
Galantamine + Placebo (Baseline)n=12 Participants	1096.75	617.45
Galantamine + Nimodipine (Week 8)n=5 Participants	852.70	480.79
Galantamine + Placebo (Week 8)n=9 Participants	1187.78	637.60
Galantamine + Nimodipine (Week 24)n=5 Participants	727.60	375.03
Galantamine + Placebo (Week 24)n=8 Participants	1116.25	540.91

Primary/registry result

Reaction Time for Face Recognition Test at Baseline, Week 8, and Week 24

Time frame:Baseline, Week 8, Week 24

descriptive

Posted result

Group	Value (mean), milliseconds	Standard deviation
Galantamine + Nimodipine (Baseline)n=9 Participants	3124.00	1461.46
Galantamine + Placebo (Baseline)n=12 Participants	2684.45	1315.44
Galantamine + Nimodipine (Week 8)n=5 Participants	2262.50	803.30
Galantamine + Placebo (Week 8)n=9 Participants	2734.25	1252.62
Galantamine + Nimodipine (Week 24)n=5 Participants	2357.80	1919.72
Galantamine + Placebo (Week 24)n=8 Participants	3099.38	1823.80

Primary/registry result

Reaction Time for Word Recognition and Learning Test at Baseline, Week 8, and Week 24

Time frame:Baseline, Week 8, Week 24

descriptive

Posted result

Group	Value (mean), milliseconds	Standard deviation
Galantamine + Nimodipine (Baseline)n=9 Participants	2022.17	672.08
Galantamine + Placebo (Baseline)n=12 Participants	2978.77	1867.62
Galantamine + Nimodipine (Week 8)n=5 Participants	1966.40	1252.10
Galantamine + Placebo (Week 8)n=9 Participants	2379.83	984.52
Galantamine + Nimodipine (Week 24)n=5 Participants	1722.00	1174.22
Galantamine + Placebo (Week 24)n=8 Participants	3038.81	1243.79

Secondary/protocol endpoint

The Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) at Baseline, Week 8, and Week 24

Time frame:Baseline, Week 8, Week 24

ADAS-Cog

descriptive

Secondary/registry result

The Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) at Baseline, Week 8, and Week 24

Time frame:Baseline, Week 8, Week 24

ADAS-Cog

descriptive

Posted result

Group	Value (mean), scores on a scale	Standard deviation
Galantamine + Nimodipine (Baseline)n=9 Participants	30.40	13.81
Galantamine + Placebo (Baseline)n=11 Participants	28.20	11.06
Galantamine + Nimodipine (Week 8)n=5 Participants	25.10	9.21
Galantamine + Placebo (Week 8)n=9 Participants	31.03	11.45
Galantamine + Nimodipine (Week 24)n=5 Participants	25.02	9.75
Galantamine + Placebo (Week 24)n=8 Participants	27.70	12.16

Behavior / neuropsychiatric

2 endpoints

Secondary/protocol endpoint

The Neuropsychiatric Inventory (NPI) at Baseline, Week 8, and Week 24

Time frame:Baseline, Week 8, Week 24

Neuropsychiatric Inventory (NPI)

event count, event

Secondary/registry result

The Neuropsychiatric Inventory (NPI) at Baseline, Week 8, and Week 24

Time frame:Baseline, Week 8, Week 24

Neuropsychiatric Inventory (NPI)

event count, event

Posted result

Group	Value (mean), scores on a scale	Standard deviation
Galantamine + Nimodipine (Baseline)n=9 Participants	24.0	14.72
Galantamine + Placebo (Baseline)n=12 Participants	26.92	20.66
Galantamine + Nimodipine (Week 8)n=5 Participants	20.20	8.67
Galantamine + Placebo (Week 8)n=12 Participants	22.11	17.93
Galantamine + Nimodipine (Week 24)n=5 Participants	15.00	11.55
Galantamine + Placebo (Week 24)n=8 Participants	19.75	16.58

Caregiver / quality of life

6 endpoints

Primary/protocol endpoint

The Quality of Life Assessment for Caregivers of Patients With Alzheimer's Disease (QoL- AD) Total Scores at Baseline, Week 8, Week 24

Time frame:Baseline, Week 8, Week 24

descriptive

Primary/protocol endpoint

The Quality of Life Assessment for Patients With Alzheimer's Disease (QoL- AD) Total Scores at Baseline, Week 8, Week 24

Time frame:Baseline, Week 8, Week 24

descriptive

Primary/protocol endpoint

The Quality of Life Assessment for Patients With Alzheimer's Disease (QoL- AD) Total Scores, Based on the Caregiver's Opinion, at Baseline, Week 8, Week 24

Time frame:Baseline, Week 8, Week 24

descriptive

Primary/registry result

The Quality of Life Assessment for Caregivers of Patients With Alzheimer's Disease (QoL- AD) Total Scores at Baseline, Week 8, Week 24

Time frame:Baseline, Week 8, Week 24

descriptive

Posted result

Group	Value (mean), scores on a scale	Standard deviation
Galantamine + Nimodipine (Baseline)n=9 Participants	34.00	6.98
Galantamine + Placebo (Baseline)n=12 Participants	36.50	7.40
Galantamine + Nimodipine (Week 8)n=5 Participants	32.00	9.03
Galantamine + Placebo (Week 8)n=9 Participants	33.56	6.84
Galantamine + Nimodipine (Week 24)n=5 Participants	36.60	4.56
Galantamine + Placebo (Week 24)n=8 Participants	34.88	6.83

Primary/registry result

The Quality of Life Assessment for Patients With Alzheimer's Disease (QoL- AD) Total Scores at Baseline, Week 8, Week 24

Time frame:Baseline, Week 8, Week 24

descriptive

Posted result

Group	Value (mean), scores on a scale	Standard deviation
Galantamine + Nimodipine (Baseline)n=9 Participants	33.56	5.59
Galantamine + Placebo (Baseline)n=12 Participants	32.67	7.02
Galantamine + Nimodipine (Week 8)n=5 Participants	35.60	3.71
Galantamine + Placebo (Week 8)n=9 Participants	33.11	4.68
Galantamine + Nimodipine (Week 24)n=5 Participants	36.60	6.23
Galantamine + Placebo (Week 24)n=7 Participants	33.86	5.27

Primary/registry result

The Quality of Life Assessment for Patients With Alzheimer's Disease (QoL- AD) Total Scores, Based on the Caregiver's Opinion, at Baseline, Week 8, Week 24

Time frame:Baseline, Week 8, Week 24

descriptive

Posted result

Group	Value (mean), scores on a scale	Standard deviation
Galantamine + Nimodipine (Baseline)n=9 Participants	28.33	8.62
Galantamine + Placebo (Baseline)n=12 Participants	29.33	8.08
Galantamine + Nimodipine (Week 8)n=5 Participants	27.80	5.36
Galantamine + Placebo (Week 8)n=9 Participants	29.78	6.69
Galantamine + Nimodipine (Week 24)n=5 Participants	29.80	5.76
Galantamine + Placebo (Week 24)n=8 Participants	29.13	7.00

Other clinical outcomes

2 endpoints

Secondary/protocol endpoint

The Clinical Global Impression (CGI) at Week 4, Week 8, Week 16, and Week 24

Time frame:Week 4, Week 8, Week 16, Week 24

descriptive

Secondary/registry result

The Clinical Global Impression (CGI) at Week 4, Week 8, Week 16, and Week 24

Time frame:Week 4, Week 8, Week 16, Week 24

descriptive

Posted result

Group	Value (number), participants	Reported bounds
Galantamine + Nimodipine (Week 4)Very much improvedn=7 Participants	0	-
Much improvedn=7 Participants	1	-
Minimally improvedn=7 Participants	1	-
No changen=7 Participants	4	-
Minimally worsen=7 Participants	1	-
Much worsen=7 Participants	0	-
Very much worsen=7 Participants	0	-
Galantamine + Placebo (Week 4)Very much improvedn=10 Participants	0	-
Much improvedn=10 Participants	1	-
Minimally improvedn=10 Participants	5	-
No changen=10 Participants	4	-
Minimally worsen=10 Participants	0	-
Much worsen=10 Participants	0	-
Very much worsen=10 Participants	0	-
Galantamine + Nimodipine (Week 8)Very much improvedn=5 Participants	0	-
Much improvedn=5 Participants	0	-
Minimally improvedn=5 Participants	2	-
No changen=5 Participants	2	-
Minimally worsen=5 Participants	1	-
Much worsen=5 Participants	0	-
Very much worsen=5 Participants	0	-
Galantamine + Placebo (Week 8)Very much improvedn=9 Participants	0	-
Much improvedn=9 Participants	1	-
Minimally improvedn=9 Participants	6	-
No changen=9 Participants	2	-
Minimally worsen=9 Participants	0	-
Much worsen=9 Participants	0	-
Very much worsen=9 Participants	0	-
Galantamine + Nimodipine (Week 16)Very much improvedn=5 Participants	0	-
Much improvedn=5 Participants	1	-
Minimally improvedn=5 Participants	2	-
No changen=5 Participants	1	-
Minimally worsen=5 Participants	1	-
Much worsen=5 Participants	0	-
Very much worsen=5 Participants	0	-
Galantamine + Placebo (Week 16)Very much improvedn=8 Participants	0	-
Much improvedn=8 Participants	0	-
Minimally improvedn=8 Participants	3	-
No changen=8 Participants	5	-
Minimally worsen=8 Participants	0	-
Much worsen=8 Participants	0	-
Very much worsen=8 Participants	0	-
Galantamine + Nimodipine (Week 24)Very much improvedn=5 Participants	0	-
Much improvedn=5 Participants	1	-
Minimally improvedn=5 Participants	3	-
No changen=5 Participants	1	-
Minimally worsen=5 Participants	0	-
Much worsen=5 Participants	0	-
Very much worsen=5 Participants	0	-
Galantamine + Placebo (Week 24)Very much improvedn=8 Participants	0	-
Much improvedn=8 Participants	2	-
Minimally improvedn=8 Participants	4	-
No changen=8 Participants	1	-
Minimally worsen=8 Participants	1	-
Much worsen=8 Participants	0	-
Very much worsen=8 Participants	0	-

Publications (1)

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

Caramelli P, Laks J, Palmini AL, Nitrini R, Chaves ML, Forlenza OV, Vale Fde A, Barbosa MT, Bottino CM, Machado JC, Charchat-Fichman H, Lawson FL. Effects of galantamine and galantamine combined with nimodipine on cognitive speed and quality of life in mixed dementia: a 24-week, randomized, placebo-controlled exploratory trial (the REMIX study). Arq Neuropsiquiatr. 2014 Jun;72(6):411-7. doi: 10.1590/0004-282x20140055.
PMID24964105via DERIVED

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.