Memantine and Down's Syndrome

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This is a study to assess whether memantine is effective and safe in preventing age related cognitive deterioration and dementia in people with Down's syndrome (DS) age 40 and over. The study will last for a year and it will include 180 people with Down's syndrome with and without dementia. Participants will be assessed on memory skills, attention and problem solving abilities. Quality of life and abilities for everyday living skills will also be regularly checked.

Primary Aims

Clinical:

• To determine the clinical efficacy of memantine versus placebo in preventing cognitive decline in people with DS.

• To compare the safety and tolerability of memantine versus placebo in people with Down's syndrome (DS).

Biochemical and pathological:

• To examine the ability of memantine to alter markers of disease progression in DS patients.

Secondary Aims

Clinical:

• To determine whether memantine has, as compared with placebo, a significant positive impact on:

• level of independent functioning as measured by the carer-rated adaptive behavioural scale, (ABS) in adults with DS;

• quality of life in adults with DS.

Biochemical and pathological:

• To investigate putative markers of memantine's mechanism of action in peripheral samples from living patients with DS.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: King's College London
• Treatments: Memantine

Criteria

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