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UnknownPhase NA

Memantine and Down's Syndrome

Efficacy and Safety of Memantine Hydrochloride, a Low Affinity Antagonist to N-Methyl-D-Aspartate (NMDA) Type Receptors, in the Prevention of Cognitive Decline and Disease Progression in Down's Syndrome

Asset

Memantine

Listed sites

2

Recruiting sites

2

Enrollment

180

Study population

Mixed / unspecified dementia

Key I/E criterion

Age ≥18

Primary endpoints

Down's Attention Memory and Executive Function ScalePart I of the Adaptive Behaviour Scale

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

SecondaryEUDRACT- 2005 000381 39
SecondaryISRCTN47562898
Org study IDKCL/DS/MEM/1
NCT IDNCT00240760

Timeline

Milestones

Study start2005-10 (month precision)
Study first posted2005-10-18estimated
Last update posted2006-02-20estimated

Assets

Drug assets

Study populations

Who this study enrolls

Mixed / unspecified dementia

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

Inclusion criteria will be:

1. Participants with learning disabilities due to Down's syndrome (DS) confirmed by karyotype. A clinical diagnosis (provided by the participant's general practitioner or hospital specialist) will be accepted if karyotype is not known and participant does not agree to have it tested

2. Ages 40 years and over or any age if a diagnosis of dementia is established

3. In participants with dementia, the diagnosis will be consistent with the 10th version of the International Classification of Diseases (ICD-10) (World Health Organization [WHO], 1992) diagnostic criteria

4. Level of speech and comprehension of verbal commands are sufficient to understand and to answer simple requests

5. Resident in care facility or community living with a carer who is willing to accept responsibility for supervising the treatment and will provide input to efficacy parameters in accordance with protocol requirements

6. Not receiving treatment with memantine currently or in past 4 weeks and responsible clinician not considering treatment with memantine

7. Participant willing to take part in study; and carer, with capacity, willing to assent to study and agrees that participant can take part if participant is also willing

Exclusion criteria

Exclusion criteria will be:

1. Participants known to have sensitivity to memantine

2. Severe, unstable or uncontrolled medical or psychiatric conditions apparent from history, physical examination or investigations

3. A current diagnosis of primary neurodegenerative disorder other than dementia such as Huntington's disease, etc.

4. Uncontrolled epilepsy

5. Presence of challenging behaviour likely to preclude the participation during testing

6. Presence of severe motor or sensory impairment (severe deafness or blindness) that renders the participant as untestable with the battery of tests used in the study

7. Current evidence of delirium

8. Severe renal impairment

9. Low probability of treatment compliance

10. Previous evidence of lack of efficacy or tolerability to memantine

11. Taking any of the following substances:

-an investigational drug during the 4 weeks prior to randomization
-a drug known to cause major organ system toxicity during the 4 weeks prior to randomization
-started any new psychotropic during the 4 weeks prior to randomization; participants who had been on a stable dose of psychotropic during the 4 weeks prior to randomization are still eligible.
-memantine during the 6 weeks prior to randomization
-other N-methyl-D-aspartate (NMDA) antagonists: amantadine, ketamine, and dextromethorphan
-barbiturates and primidone
-baclofen and dantrolen
-dextromethorphan
-antimuscarinics

Endpoints (4)

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

Memory
1
Behavior / neuropsychiatric
1
Caregiver / quality of life
1
Other (unclassified)
1

Memory

1 endpoint
Primary/protocol endpoint

Down's Attention Memory and Executive Function Scale

descriptive

Behavior / neuropsychiatric

1 endpoint
Primary/protocol endpoint

Part I of the Adaptive Behaviour Scale

descriptive

Caregiver / quality of life

1 endpoint
Secondary/protocol endpoint

The Quality of Life in Alzheimer's Disease (Logsdon et al. 1998)

descriptive

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

Clinician's Global Impression of Change

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

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.