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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
Lead sponsor
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 Scale•Part 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
Timeline
Milestones
Assets
Drug assets
Study populations
Who this study enrolls
Eligibility
Who can enroll
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:
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 endpointDown's Attention Memory and Executive Function Scale
descriptive
Behavior / neuropsychiatric
1 endpointPart I of the Adaptive Behaviour Scale
descriptive
Caregiver / quality of life
1 endpointThe Quality of Life in Alzheimer's Disease (Logsdon et al. 1998)
descriptive
Other (unclassified)
1 endpointClinician's Global Impression of Change
descriptive
Provenance
Sources
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.